Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein (RECoN)
|Varicose Veins Venous Insufficiency||Device: VNUS RF ClosureFAST Device: VenaCure EVLT NeverTouch|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Subjects Comparing the NeverTouch Versus the RF ClosureFAST Methods of Treatment of the Great Saphenous Vein|
- Incidence of post operative adverse events/ effects between the two treatment groups. [ Time Frame: Evaluated on the day of treatment (post treatment), 2, 7, 14, and 30 days and 6 and 12 months post treatment follow up visits. ]
- Evaluation of GSV closure and incidence of DVT via duplex ultrasound between the two treatment groups. [ Time Frame: Evaluated at 7 and 30 days post treatment and 6 and 12 months post treatment follow up visits. ]
- Presence and intensity of post operative pain between the two treatment groups. [ Time Frame: Evaluated at 2, 7, 14 and 30 days and 6 and 12 months post treatment follow up visits. ]The VAS scale for pain will be used through the 30 day follow up time period. The questionnaires for quality of life will be used for each of the visits including the 6 and 12 month follow up visits.
- Presence and intensity of post operative ecchymosis between the two treatment groups. [ Time Frame: Evaluated 2, 7, 14 and 30 days post treatment follow up visits. ]A blinded healthcare professional (selected by the PI at each site) will evaluate the subject at the designated timepoints.
- Use of Analgesics within the 30 days post treatment between the two treatment groups. [ Time Frame: Reviewed at 2, 7, 14 and 30 days post treatment follow up visits. ]
- Evaluation of subject quality of life between the two treatment groups. [ Time Frame: Completed at 2, 7, 14 and 30 days and 6 and 12 months post treatment follow up visits. ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: VenaCure EVLT NeverTouch||
Device: VenaCure EVLT NeverTouch
Endovenous Laser Treatment (EVLT) uses laser energy, which is a highly concentrated beam of light to treat varicose veins.
|Active Comparator: RF ClosureFAST||
Device: VNUS RF ClosureFAST
VNUS® RF ClosureFAST is a minimally invasive varicose vein treatment procedure that uses radiofrequency energy (electricity) to heat, collapse and seal off the targeted blood vessels.
Other Name: Closure
Some form of venous insufficiency affects up to 25% of men and 40% of women in the United States. While most persons seek treatment because varicose veins are unsightly, most will also experience symptoms such as aching pain, night cramps, leg fatigue, leg heaviness or leg restlessness. If left untreated, nearly 50% of patients with significant superficial venous insufficiency will experience chronic venous insufficiency characterized by lower extremity swelling, eczema, pigmentation, hemorrhage and ulceration.
This is a multicenter, prospective, randomized study in subjects with symptomatic venous insufficiency of the great saphenous vein. Subjects evaluated for participation will be those who, prior to the first visit, have elected to receive invasive treatment for the GSV insufficiency and have already received conservative treatment (i.e. use of compression hose).
Subjects will be randomized to receive one of two methods of treatment. VenaCure EVLT NeverTouch method of treatment or the RF ClosureFAST method of treatment.
Follow up visits will take place at 2, 7, 14 and 30 days post treatment where questionnaires (SF-36, CIVI Q2, Visual Analogue Scale), evaluation of GSV closure via duplex ultrasound (7 day and 30 day only), evaluation of ecchymosis, physician (or their designee) evaluation of venous disease (CEAP assessment and VCSS assessment), assessments of adverse events and review of concomitant medications (use of analgesics and other medications)will take place. These same evaluations with the exception of the use of the Visual Analogue Scale and the Ecchymosis evaluation will also take place at the 6 month and 12 month follow up visit timepoints.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173419
|United States, California|
|UC Davis Interventional and Vascular Radiology|
|Sacramento, California, United States, 95817|
|United States, Florida|
|Batey Cardiovascular and Vein Center|
|Bradenton, Florida, United States, 34209|
|United States, Illinois|
|Midwest Institute for Minimally Invasive Therapies (MIMIT)|
|Melrose Park, Illinois, United States, 60160|
|United States, Michigan|
|Novi Vein Center|
|Novi, Michigan, United States, 48377|
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||David Gillespie, MD||University of Rochester|