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Active Not RecruitingNCT05504070

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
203 (estimated)
Sponsor
C. R. Bard · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEVenclose 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.
DEVICEVenclose 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.

Timeline

Start date
2023-09-08
Primary completion
2025-07-17
Completion
2027-06-01
First posted
2022-08-17
Last updated
2026-03-18

Locations

7 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05504070. Inclusion in this directory is not an endorsement.