RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study

Stopped early · Not applicable

Conditions studied: Venous Insufficiency

In brief

The purpose of this study is to demonstrate that patients will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator veins (IPVs).

Key facts

Study ID

NCT01079598

Run by

Medtronic Endovascular

People needed

8

Starts

2010-03-01

Expected to finish

2011-01-01

Last updated by the study team

2017-05-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Varicosity Vein Center — Birmingham, Alabama, United States
• Vein Care Pavilion of the South — Evans, Georgia, United States
• Allegiance Vascular Health — Jackson, Michigan, United States

Full record on ClinicalTrials.gov

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