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This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).
Subjects who meet eligibility criteria will undergo a procedure using the Venclose Radiofrequency (RF) System to treat the great saphenous vein.
The technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (EVSRFâ„¢) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. After each treatment, the EVSRFâ„¢ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.
After the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venclose RF System | Other | Treatment of great saphenous vein (GSV) using Venclose RF System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venclose RF System | Device | Treatment of great saphenous vein (GSV) using Venclose RF System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | 3 days |
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | 3 months |
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | 6 months |
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | 12 months |
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein | 3 days |
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein | 3 months |
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein | 6 months |
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | Baseline |
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Mattausch, Dr. med | Venenzentrum am Bruehl | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Venenzentrum am Bruehl | Leipzig | 04109 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20875713 | Background | Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Venclose RF System | Treatment of great saphenous vein (GSV) using Venclose RF System Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venclose RF System | Treatment of great saphenous vein (GSV) using Venclose RF System Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | limbs | 3 days | limbs | limbs |
|
|
Adverse event data were collected from time of treatment through one year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venclose RF System | Treatment of great saphenous vein (GSV) using Venclose RF System Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-occlusive DVT | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mai-Ly Wilcox | Venclose, Inc. | 415-254-1930 | mwilcox@venclose.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2019 | Feb 15, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) |
| 3 days |
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer | 3 months |
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | 6 months |
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | 12 months |
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | Baseline |
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 3 days |
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 3 months |
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 6 months |
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 12 months |
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention | up to 3 days |
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention | 3 months |
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention | 6 months |
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention | 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| limbs |
|
|
| Primary | Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 3 months | Limbs | Limbs |
|
|
|
| Primary | Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 6 months | Limbs | Limbs |
|
|
|
| Primary | Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 12 months | Limbs | Limbs |
|
|
|
| Primary | Reflux-free Rate | Percentage of limbs without reflux in the treated vein | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 3 days | Limbs | Limbs |
|
|
|
| Primary | Reflux-free Rate | Percentage of limbs without reflux in the treated vein | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 3 months | Limbs | Limbs |
|
|
|
| Primary | Reflux-free Rate | Percentage of limbs without reflux in the treated vein | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 6 months | Limbs | Limbs |
|
|
|
| Primary | Reflux-free Rate | Percentage of limbs without reflux in the treated vein | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 12 months | Limbs | Limbs |
|
|
|
| Secondary | Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | Baseline | Limbs | Limbs |
|
|
|
| Secondary | Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 3 days | Limbs | Limbs |
|
|
|
| Secondary | Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 3 months | Limbs | Limbs |
|
|
|
| Secondary | Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 6 months | Limbs | Limbs |
|
|
|
| Secondary | Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Count of Units | Limbs | 12 months | Limbs | Limbs |
|
|
|
| Secondary | Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Mean | Standard Deviation | score on a scale | Baseline | Limbs | Limbs |
|
|
|
| Secondary | Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Mean | Standard Deviation | score on a scale | 3 days | Limbs | Limbs |
|
|
|
| Secondary | Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Mean | Standard Deviation | score on a scale | 3 months | Limbs | Limbs |
|
|
|
| Secondary | Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Mean | Standard Deviation | score on a scale | 6 months | Limbs | Limbs |
|
|
|
| Secondary | Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Mean | Standard Deviation | score on a scale | 12 months | Limbs | Limbs |
|
|
|
| Secondary | Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Number | Limbs | up to 3 days | Limbs | Limbs |
|
|
|
| Secondary | Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Number | Limbs | 3 months | Limbs | Limbs |
|
|
|
| Secondary | Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Number | Limbs | 6 months | Limbs | Limbs |
|
|
|
| Secondary | Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention | Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated. | Posted | Number | Limbs | 12 months | Limbs | Limbs |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 5 |
| 25 |
| Muscle vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Pain | Vascular disorders | Systematic Assessment |
|
| Lymphedema | Blood and lymphatic system disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
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| C3: Edema |
|
| C4a: Pigmentation or eczema |
|
| C4b: Lipodermatosclerosis or atrophie blanche |
|
| C5: Healed venous ulcer |
|
| C6: Active venous ulcer |
|
| C3: Edema |
|
| C4a: Pigmentation or eczema |
|
| C4b: Lipdermatosclerosis or atrophie blanche |
|
| C5: Healed venous ulcer |
|
| C6: Active venous ulcer |
|
| C3: Edema |
|
| C4a: Pigmentation or eczema |
|
| C4b: Lipodermatosclerosis or atrophie blanche |
|
| C5: Healed venous ulcer |
|
| C6: Active venous ulcer |
|
| C3: Edema |
|
| C4a: Pigmentation or eczema |
|
| C4b: Lipodermatosclerosis or atrophie blanche |
|
| C5: Healed venous ulcer |
|
| C6: Active venous ulcer |
|
| C3: Edema |
|
| C4a: Pigmentation or eczema |
|
| C4b: Lipodermatosclerosis or atrophie blanche |
|
| C5: Healed venous ulcer |
|
| C6: Active venous ulcer |
|
| Title | Measurements |
|---|---|
|
| Thermal skin injury |
|
| Skin discoloration or pigmentation |
|
| Infection |
|
| Neurological injury |
|
| Paresthesia |
|
| Superficial venous thrombophlebitis |
|
| Edema |
|
| Ecchymosis |
|
| Hematoma |
|
| Erythema |
|
| EHIT II (non-occlusive DVT) |
|
| Deep vein thrombosis (DVT) or pulmonary embolism (PE) |
|
| Title | Measurements |
|---|---|
|
| Thermal skin injury |
|
| Skin discoloration or pigmentation |
|
| Infection |
|
| Neurological injury |
|
| Paresthesia |
|
| Superficial venous thrombophlebitis |
|
| Edema |
|
| Ecchymosis |
|
| Hematoma |
|
| Erythema |
|
| EHIT II (non-occlusive DVT) |
|
| Deep vein thrombosis (DVT) or pulmonary embolism (PE) |
|
| Title | Measurements |
|---|---|
|
| Thermal skin injury |
|
| Skin discoloration or pigmentation |
|
| Infection |
|
| Neurological injury |
|
| Paresthesia |
|
| Superficial venous thrombophlebitis |
|
| Edema |
|
| Ecchymosis |
|
| Hematoma |
|
| Erythema |
|
| EHIT II (non-occlusive DVT) |
|
| Deep vein thrombosis (DVT) or pulmonary embolism (PE) |
|
| Title | Measurements |
|---|---|
|
| Thermal skin injury |
|
| Skin discoloration or pigmentation |
|
| Infection |
|
| Neurological injury |
|
| Paresthesia |
|
| Superficial venous thrombophlebitis |
|
| Edema |
|
| Ecchymosis |
|
| Hematoma |
|
| Erythema |
|
| EHIT II (non-occlusive DVT) |
|
| Deep vein thrombosis (DVT) or pulmonary embolism (PE) |
|