New radiofrequency device aims to seal off problem veins
NCT ID NCT05504070
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device that uses radiofrequency energy to close off damaged veins in the legs, helping blood flow better and easing symptoms like pain and swelling. About 200 adults with chronic venous insufficiency are taking part. The main goals are to see if the treated veins stay closed and to check for serious side effects like blood clots.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 203 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject is age 18 and older 2. Subject has CEAP clinical class C2 and higher. 3. Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated. 4. 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. 5. For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm. 6. For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm. 7. For IPV only: IPVs must be located under a healed or active ulcer. 8. Is able to ambulate. 9. Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study. 10. Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule. Exclusion Criteria: 1. Has had previous treatment for venous insufficiency in the same target vein. 2. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site. 3. Has thrombus in the vein segment to be treated. 4. Has untreated critical limb ischemia from peripheral arterial disease. 5. 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. 6. Subjects with known bleeding and/or clotting disorders. 7. Has ABI \<0.8 8. Subject is pregnant or breastfeeding 9. For GSV/SSV only: has a BMI \>35. 10. For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein). 11. Unable to ambulate, or restrictive ambulation. 12. Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy). 13. Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure. 14. Has a condition, judged by the treating physician, that may jeopardize the subject's well-being and/or confound the results or the soundness of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Atrium Health
Charlotte, North Carolina, 28204, United States
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Christus Health
Tyler, Texas, 75702, United States
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ClinRe
Thornton, Colorado, 80602, United States
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ClinRe
Colonial Heights, Virginia, 23834, United States
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Eastlake Cardiovascular
Roseville, Michigan, 48066, United States
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Englewood Hospital
Englewood, New Jersey, 07631, United States
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Pacific Vascular Institute
Kailua, Hawaii, 96740, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Tiny trial tests artificial vein valve for leg swelling