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Venclose digiRF System Post Market Study | Clinical Trials | Clareo Health

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Venclose digiRF System Post Market Study

Venclose digiRF System: 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

NCT05504070•C. R. Bard

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+4 more criteria

Locations (7)

ClinRe

Thornton, Colorado, United States

Pacific Vascular Institute

Kailua, Hawaii, United States

Eastlake Cardiovascular

Roseville, Michigan, United States

Englewood Hospital

Englewood, New Jersey, United States

Atrium Health

Charlotte, North Carolina, United States

Christus Health

Tyler, Texas, United States

ClinRe

Colonial Heights, Virginia, United States

Key Dates

Start Date

September 8, 2023

Primary Completion Date

July 17, 2025

Completion Date

June 1, 2027

Last Updated

March 18, 2026

Enrollment

203

ESTIMATED participants

Conditions

Venous RefluxChronic Venous Insufficiency

Interventions

Venclose System (digiRF generator w EVSRF catheter)

DEVICE

Venclose MAVEN System (digiRF generator w MAVEN catheter)

DEVICE

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

NCT07449728

Varicose VeinsChronic Venous Insufficiency

View study

RECRUITINGNA

Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

NCT06811909

Non-infected Venous Leg UlcerVenous Leg Ulcer+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Venclose digiRF System Post Market Study

Inclusion Criteria

Exclusion Criteria

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over

Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery

Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)