Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm: Endovascular thermal ablation in IPV | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins | Device | The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study. | 3-day post-procedure |
| Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study. | 15-day post-procedure |
| Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study. | 30-day post-procedure |
| Effectiveness: Technical Success | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. | Day of procedure |
| Effectiveness: Successful Access and Entry Into the IPV | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. | 3-day post ablation |
| Effectiveness: Technical Success | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Ablation Success | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. | 3-day post-procedure follow-up |
| Acute Ablation Success |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Carr, MD | Vein Center of East Texas at CardioStream | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vein Center of East Texas at CardioStream | Tyler | Texas | 75701 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single-arm: Endovascular Thermal Ablation in IPV | Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single-arm: Endovascular Thermal Ablation in IPV | Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound. |
| 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 | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study. | Posted | Number | Events | 3-day post-procedure |
|
AEs, SAEs, ADEs, SADEs, UADEs were captured for each participant at Baseline, Day of Procedure, and then 3-day, 15-day, and 30-day post-procedure follow-up visits.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-arm: Endovascular Thermal Ablation in IPV | Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mai-Ly Wilcox | Venclose | 415-254-1930 | mwilcox@venclose.com |
Not provided
| 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 | Apr 14, 2020 | Mar 24, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2020 | Mar 24, 2022 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 15-day post ablation |
| Effectiveness: Technical Success | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. | 30-day post ablation |
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. |
| 15-day post-procedure |
| Acute Ablation Success | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. | 30-day post-procedure |
| Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | 3-day post-procedure |
| Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | 15-day post-procedure |
| Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | 30-day post-procedure |
| IPVs |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Weight | Mean | Standard Deviation | pounds | Participants |
|
|
| Height | Mean | Standard Deviation | inches | Participants |
|
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 | Participants |
|
|
| Number of Veins | Count of Units | IPVs | IPVs |
|
|
| CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by the physician using the Clinical Etiologic Anatomic Pathophysiologic (CEAP) system. C0: No visible or palpable signs of venous disease C1: Telangiectasias or reticular veins C2: Varicose veins C3: Edema C4: Changes in skin and subcutaneous tissue secondary C5: Healed C6: Active venous ulcer | Count of Units | IPVs | IPVs |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study. | Posted | Number | Events | 15-day post-procedure |
|
|
|
| Primary | Safety: AEs, SAEs, ADEs, SADEs, UADEs | Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study. | Posted | Number | Events | 30-day post-procedure |
|
|
|
| Primary | Effectiveness: Technical Success | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. | Posted | Count of Units | IPVs | Day of procedure | IPVs | IPVs |
|
|
|
| Primary | Effectiveness: Successful Access and Entry Into the IPV | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. | Posted | Count of Units | IPVs | 3-day post ablation | IPVs | IPVs |
|
|
|
| Primary | Effectiveness: Technical Success | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. | Posted | Count of Units | IPVs | 15-day post ablation | IPVs | IPVs |
|
|
|
| Primary | Effectiveness: Technical Success | Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated. | Posted | Count of Units | IPVs | 30-day post ablation | IPVs | IPVs |
|
|
|
| Secondary | Acute Ablation Success | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. | Posted | Count of Units | IPVs | 3-day post-procedure follow-up | IPVs | IPVs |
|
|
|
| Secondary | Acute Ablation Success | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. | Posted | Count of Units | IPVs | 15-day post-procedure | IPVs | IPVs |
|
|
|
| Secondary | Acute Ablation Success | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. | Posted | Count of Units | IPVs | 30-day post-procedure | IPVs | IPVs |
|
|
|
| Secondary | Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | Posted | Count of Units | IPVs | 3-day post-procedure | IPVs | IPVs |
|
|
|
| Secondary | Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | Posted | Count of Units | IPVs | 15-day post-procedure | IPVs | IPVs |
|
|
|
| Secondary | Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | Posted | Count of Units | IPVs | 30-day post-procedure | IPVs | IPVs |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
Not provided
Not provided
|
| C4 |
|
| C5 |
|
| C6 |
|
| Title | Measurements |
|---|---|
|
| SADEs |
|
| UADEs |
|
| Title | Measurements |
|---|---|
|
| SADEs |
|
| UADEs |
|