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New radiofrequency device aims to seal off problem veins

NCT ID NCT05504070

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 203 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Atrium Health

    Charlotte, North Carolina, 28204, United States

  • Christus Health

    Tyler, Texas, 75702, United States

  • ClinRe

    Thornton, Colorado, 80602, United States

  • ClinRe

    Colonial Heights, Virginia, 23834, United States

  • Eastlake Cardiovascular

    Roseville, Michigan, 48066, United States

  • Englewood Hospital

    Englewood, New Jersey, 07631, United States

  • Pacific Vascular Institute

    Kailua, Hawaii, 96740, United States

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