VenaSeal Spectrum: Global Post-Market Randomized Controll... | NCT03820947

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ System	Experimental	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA	Device: VenaSeal™ System
Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETA	Active Comparator	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA	Device: Endothermal Ablation (ETA)
Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ System	Experimental	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping	Device: VenaSeal™ System
Randomized study VenaSeal™ System versus Surgical Stripping: Surgical Stripping	Active Comparator	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping	Procedure: Surgical Stripping
Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	Experimental	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VenaSeal™ System	Device	The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.	30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.	30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.	30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.	30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.

Secondary Outcomes

Measure	Description	Time Frame
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.	Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is ≥18 years of age
Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS)
Eligibility for treatment:
- VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA
- VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping
- VLU Study: patients should be eligible for treatment with the VenaSeal™ system
Treatable refluxing segment of target vein(s) 10 cm in length or longer
Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
Patient is willing and capable of complying with specified follow-up evaluations at the specified times
Patient has an ability to understand the requirements of the study and to provide informed consent

Exclusion Criteria:

Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity
Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
Patient has abnormal pulse exam or ABI <0.8
Patient has acute superficial thrombophlebitis
Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure
Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)
IFU contraindications:
- VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s)
- VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)
- VLU Study: Patient has VenaSeal™ system IFU contraindication(s)
Patient is non-ambulatory
Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure
Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures
Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study
Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.
VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory
VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)

Name	Affiliation	Role
Kathleen Gibson, MD	Lake Washington Vascular, US	Principal Investigator
Manjit Gohel, MD	Addenbrooke's Hospital, UK	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yavapai Regional Medical Center		Prescott Valley	Arizona	86314-2255	United States
PIMA Heart and Vascular

PubMed Identifier	Type	Citation	Retractions
42203167	Derived	Gohel M, Gibson K, Falvo N, Park SW, Kim JY, Hirsch T, O'Banion LA, Salkowski N, Ali A, Davies AH; VenaSeal Spectrum Investigators. Randomised Clinical Trials Comparing Cyanoacrylate Closure with Surgical Stripping and Endovenous Thermal Ablation for Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2026 May 26:S1078-5884(26)00465-X. doi: 10.1016/j.ejvs.2026.05.005. Online ahead of print.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 31, 2022	Apr 30, 2025

Arm/Group Information

ID	Title	Description
BG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
BG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
BG002	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
BG003	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
BG004	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000131 ParticipantsBG001130 ParticipantsBG00250 ParticipantsBG003

Sex/Gender, Customized

Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.

Count of Participants

Participants

Title	Denominators	Categories
Female	ParticipantsBG000131 ParticipantsBG001130 ParticipantsBG002

Race/Ethnicity, Customized

Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.

Race is not allowed to be collected per local laws or regulations in the following countries: France, Germany, Italy, The Netherlands, Spain, United Kingdom. Subjects could report more than one races; therefore the column total might be more than the study arm total.

Count of Participants

Participants

Title	Denominators	Categories
Not reportable per local laws or regulations	ParticipantsBG000131 ParticipantsBG001130

Body Mass Index

Overall Number of Baseline Participants is the number of ITT. The number analyzed participants is the number with available data for this baseline measure.

Mean

Standard Deviation

kg/m2

Title	Denominators	Categories
	ParticipantsBG000131 ParticipantsBG001130 ParticipantsBG002

CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification

Clinical Classification per 2004 guidelines C0: no visible or palpable signs of venous disease C1: telengiectasies or reticular veins C2: variose veins C3: edema C4a: pigmentation and eczema C4b: lipodermatosclerosis and atrophie blanche C5: healed venous ulcer C6: active venous ulcer Higher score means more advanced venous disease progression

Count of Participants

Participants

Title	Denominators	Categories
C0	ParticipantsBG000136 ParticipantsBG001139 Participants

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

Posted

Mean

Standard Deviation

score on a scale

30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Units	Counts
Participants	OG000123 OG001119

Title

Denominators

Categories

Title	Measurements
	OG00030.8± 4.22 OG00129.6± 4.73

Primary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

Posted

Mean

Standard Deviation

score on a scale

30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts
Participants

Primary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

Posted

Mean

Standard Deviation

score on a scale

30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Primary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

Posted

Mean

Standard Deviation

score on a scale

30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts
Participants

Primary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.

Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

Posted

Mean

Standard Deviation

% of vein length

Post Index procedure, on the day of the procedure immediately following treatment

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Primary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.

Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

Target Veins based measurement. Number of units analyzed units corresponds to number of target veins with available data.

Posted

Mean

Standard Deviation

% of vein length

Post Index procedure, on the day of the procedure immediately following treatment

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Primary

Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.

Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.

Posted

Number

percentage probability

12 months

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures.

Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Posted

Number

percentage probability

6 months

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Posted

Number

percentage probability

6 months

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Posted

Number

percentage probability

6 months

Target Veins

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

Posted

Number

percentage probability

30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

Posted

Number

percentage probability

30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts
Participants

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

Posted

Number

percentage probability

30 days

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.

For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Posted

Number

percentage probability

30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months.

Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Posted

Number

percentage probability

30 days, 12 months

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.

For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.

Posted

Number

percentage probability

30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Target Veins

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.

For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.

Posted

Number

percentage probability

30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months.

Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures.

Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.

Posted

Number

percentage probability

30 days, 6, 12 months

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.

For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.

Posted

Number

percentage probability

30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Target Veins

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

Posted

Count of Units

Target Veins

Post Index procedure, on the day of the procedure immediately following treatment

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.

Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

Posted

Count of Units

Target Veins

Post Index procedure, on the day of the procedure immediately following treatment

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Target veins based measurement. Number of analyzed units corresponds to number of target veins with available data.

Posted

Count of Units

Target Veins

Post Index procedure, on the day of the procedure immediately following treatment

Target Veins

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.

Rate based measurement; rate corresponds to count of reinterventions over the total vein-years (sum of patient follow-up time until reintervention, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.

Posted

Number

reintervention per vein-years

12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.

As measured by the time between the index procedure and the first reintervention procedure.

Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.

Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

Posted

Number

percentage probability

12 months

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Units

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts
Participants

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months.

Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

Rate based measurement; rate corresponds to the count of adjunctive procedures over the total vein-years (sum of patient follow-up time until adjunct procedure, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.

Posted

Number

adjunctive treatment per vein-years

12 months

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

Posted

Number

adjunctive treatment per vein-years

12 months

Target Veins

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

Posted

Number

adjunctive treatment per vein-years

12 months

Target Veins

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.

Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.

Rate based measurement; rate corresponds to the count of healthcare utilization over the total person-years (sum of patient follow-up time until Health Care Utilization, 12 months, or exit if before 12 months) among patients in the ITT cohort.

Posted

Number

services utilized per person-years

12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

Posted

Number

percentage probability

30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

Posted

Number

percentage probability

30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts
Participants

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

Posted

Number

percentage probability

30 days

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline.

Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

7 and 30 days, and at 6 and 12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline.

The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6 and 12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.

EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline.

EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6 and 12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.

EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

The total score ranges from 0 to 100, with higher scores indicating better general health perception.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6 and 12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

The total score ranges from 0 to 100, with higher scores indicating better general health perception.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6 and 12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

The total score ranges from 0 to 100, with higher scores indicating better general health perception.

The outcome measure data reports changes compared to baseline at the different time frames.

Overall Number of Participants Analyzed is the number of participants that were treated.

Posted

Mean

Standard Deviation

score on a scale

30 days, and 6 and 12 months

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad.

Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse.

The outcome measure data reports the responses at the different time frames including baseline.

Overall Number of Participants Analyzed is the number of participants with data at baseline.

Posted

Count of Participants

Participants

30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline.

Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad.

Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse.

The outcome measure data reports the responses at the different time frames including baseline.

Overall Number of Participants Analyzed is the number of participants with data at baseline

Posted

Count of Participants

Participants

30 days, and 6, 12 months

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad.

Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse.

The outcome measure data reports the responses at the different time frames including baseline.

Overall Number of Participants Analyzed is the number of participants with data at baseline.

Posted

Count of Participants

Participants

30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts

Secondary

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

Posted

Count of Participants

Participants

Post-index procedure, on the day of the procedure immediately following treatment

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Units

Secondary

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

Posted

Count of Participants

Participants

Post-index procedure, on the day of the procedure immediately following treatment

ID	Title	Description
OG000	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
OG001	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Units	Counts
Participants

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

Posted

Count of Participants

Participants

Post-index procedure, on the day of the procedure immediately following treatment

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

Posted

Mean

Standard Deviation

score on a scale

30 days

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

Posted

Mean

Standard Deviation

score on a scale

30 days

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Secondary

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated.

Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.

Posted

Mean

Standard Deviation

% of vein length

Post-index procedure, on the day of the procedure immediately following treatment

Target Veins

ID	Title	Description
OG000	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	0	136	3	136	21	136
EG001	Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.	0	139	6	139	5	139
EG002	Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	0	53	1	53	9	53
EG003	Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping	CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.	0	53	2	53	4	53
EG004	Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System	CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.	10	125	33	125	38	125

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG0030 events0 affected53 at risk EG0042 events2 affected125 at risk
Nephrogenic Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Aortic Valve Stenosis	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Cardiac Failure	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Cardiac Failure Congestive	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Supraventricular Tachycardia	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Thyroid Mass	Endocrine disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Retinal Detachment	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected139 at risk EG0020 events0 affected53 at risk EG003
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Chest Pain	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected139 at risk EG0020 events0 affected53 at risk EG003
Death	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Cellulitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Cellulitis Staphylococcal	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Covid-19	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Covid-19 Pneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Enterobacter Bacteraemia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Extradural Abscess	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Infective Exacerbation Of Chronic Obstructive Airways Disease	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected139 at risk EG0020 events0 affected53 at risk EG003
Phlebitis Infective	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected139 at risk EG0020 events0 affected53 at risk EG003
Pneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Pneumonia Aspiration	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Pulmonary Sepsis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Septic Shock	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Streptococcal Bacteraemia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Wound Infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Periprosthetic Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected139 at risk EG0020 events0 affected53 at risk EG003
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Breast Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected139 at risk EG0020 events0 affected53 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Acute Kidney Injury	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Bladder Mass	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected139 at risk EG0020 events0 affected53 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Loss Of Personal Independence In Daily Activities	Social circumstances	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Arteriovenous Fistula	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Extremity Necrosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Haematoma	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Peripheral Venous Disease	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Phlebitis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0021 events1 affected53 at risk EG003
Subclavian Vein Occlusion	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Superficial Vein Thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypersensitivity	Immune system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0008 events8 affected136 at risk EG0011 events1 affected139 at risk EG0025 events5 affected53 at risk EG0030 events0 affected53 at risk EG0040 events0 affected125 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected139 at risk EG0020 events0 affected53 at risk EG003
Peripheral Venous Disease	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected139 at risk EG0021 events1 affected53 at risk EG003
Phlebitis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0009 events8 affected136 at risk EG0010 events0 affected139 at risk EG0021 events1 affected53 at risk EG003
Venous Recanalisation	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 events5 affected136 at risk EG0013 events3 affected139 at risk EG0022 events2 affected53 at risk EG003

ID	Term
D014647	Varicose Ulcer
D014648	Varicose Veins

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative