Venclose digiRF System Post Market Study (NCT05504070) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Venclose digiRF System Post Market Study
United States203 participantsStarted 2023-09-08
Plain-language summary
A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is age 18 and older
. Subject has CEAP clinical class C2 and higher.
. Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
. GSV/SSV or IPV to be treated that has an outward flow reflux duration of ≥ 0.5 seconds immediately after release of manual distal compression with subject standing or in Reverse Trendelenburg.
. For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
. For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm.
. For IPV only: IPVs must be located under a healed or active ulcer.
. Is able to ambulate.
Exclusion criteria
. Has had previous treatment for venous insufficiency in the same target vein.
. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Has untreated critical limb ischemia from peripheral arterial disease.
. Is undergoing active anticoagulant therapy for acute Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
. Subjects with known bleeding and/or clotting disorders.