ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.

Study Overview
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Brief Summary
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The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.

Detailed Description
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Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.

Official Title
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Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)

Conditions
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Venous Reflux

Intervention / Treatment
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* Device: Seg. RF Ablation & ClosureFAST catheter
* Device: Endovenous Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must provide written informed consent. Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser. Exclusion Criteria: Subjects who require additional treatments in either leg within 30 days before or after the study procedure. Subjects who are participating in another investigational study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Seg. RF Ablation & ClosureFAST catheter<br>Seg. RF Ablation & ClosureFAST catheter | Device: Seg. RF Ablation & ClosureFAST catheter<br>* Seg. RF Ablation & ClosureFAST catheter<br>* Other names: VNUS;|
| Active Comparator: Endovenous Laser<br>Treatment invention of venous disease with an Endovenous Laser. | Device: Endovenous Laser<br>* laser catheter<br>* Other names: Commercially approved laser catheter systems.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain 0-10 scale (10 most severe) | 48 Hour | 
| Pain | Pain 0-10 scale (10 most severe) | 1 Week | 
| Pain | Pain 0-10 scale (10 most severe) | 2 Weeks | 
| Pain | Pain 0-10 scale (10 most severe) | 1 Month | 
| Tenderness | Tenderness 0-10 scale (10 most severe) | 48 Hour | 
| Tenderness | Tenderness 0-10 scale (10 most severe) | 1 Week | 
| Tenderness | Tenderness 0-10 scale (10 most severe) | 2 Weeks | 
| Tenderness | Tenderness 0-10 scale (10 most severe) | 1 Month | 
| Ecchymosis | 0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below treated (tx) segment | 48 Hours post treatment (no baseline) | 
| Ecchymosis | 0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment | 1 Week post treatment (no baseline) | 
| Ecchymosis | 0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment | 2 Weeks post treatment (no baseline) | 
| Ecchymosis | 0-5 scale (5 most severe) 0: None <25% 25-50% 50-75% 75-100% Above or below tx segment | 1 Month post treatment (no baseline) | 
| Complications | Sequelae at any follow-up | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | 48 Hours | 
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | 1 Week | 
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | 2 Weeks | 
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | 1 Month | 
| Change in CIVIQ QOL | Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline | 48 Hours | 
| Change in CIVIQ QOL | Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline | 1 Week | 
| Change in CIVIQ QOL | Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline | 2 Week | 
| Change in CIVIQ QOL | Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose veins, venous reflux, GSV disease