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Venclose digiRF System Post Market Study

NCT05504070 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Venous Reflux
  • Chronic Venous Insufficiency

Interventions

DEVICE

Venclose System (digiRF generator w EVSRF catheter)

The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.

DEVICE

Venclose MAVEN System (digiRF generator w MAVEN catheter)

The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2025-07-17
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05504070 on ClinicalTrials.gov