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 range18 Years

SexALL

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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.
✕. Has thrombus in the vein segment to be treated.
✕. 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.
✕. Has ABI \<0.8
✕. Subject is pregnant or breastfeeding

What they're measuring

Occlusion

Timeframe: 1-Month

DVT & PE Serious Adverse Events

Timeframe: 1-Month

Trial details

NCT IDNCT05504070

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-17

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