RFS - Radiofrequency Perforator Vein Treatment Study (TRIPLE)

Inclusion Criteria:

• Male and female, ages 18 to 80 years, from all racial and ethnic origin
• Have the ability to understand the requirements of the study, provide written informed consent to participate, and agree to abide by the study requirements
• Available for all the follow-up visits and in a physical condition allowing ambulation after the procedure
• Incompetent GSV and/or SSV in the target limb has been treated at least 3 months before study enrollment or competent GSV and SSV at time of treatment
• CEAP 4 - 6 classification
• DUS reflux of ≥0.35 sec or more of the target IPV and/or an intra-fascia diameter of ≥0.3 mm

Exclusion Criteria:

• Acute (at Screening) superficial venous thrombosis of either limb
• Acute (within the prior 3 months) deep venous thrombosis or phlebitis in either limb
• Complete or near complete deep venous obstruction documented by ultrasound
• Previously participated in any study involving ClosureRFS
• Actively participated in any other investigational study within 30 days of enrollment into this study
• Pregnant at the time of treatment. Status verified by pregnancy test via blood or urine for women ≤ 55 years old.
• Having a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all required study follow-up
• Have any condition that, in the opinion of the Investigator, would jeopardize the safety of the patient or affect the validity of the trial results
• Have a history of excessive alcohol consumption or any use of illegal drugs rendering the patient unreliable, or at risk during this trial
• Have undergone major surgery which may result in abnormalities of the target body area, reasonably suspected to compromise the study outcomes
• Have undergone an invasive procedure of the target body area (e.g., needle biopsy or surgical procedure) within 30 days of enrollment into this study
• Known incompatibility, such as an allergic reaction to anesthetics to be used in the incompetent perforator vein treatment
• Patients requiring hyperbaric therapy involving the treated limb during the 6 month post treatment follow-up period
• Great toe pressure measurement of ≤ 70 mmHg
• CEAP 6 classified patients receiving high dose steroid medication or the following medications that interfere with normal mechanisms of wound healing, e.g. glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), anti-neoplastic and immunosuppressive drugs, and others like, colchicine and penicillamine.
• Expressing a body mass index (BMI) of ≥ 35.