Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein

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.