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EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

NCT04236245 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-04-04

Study results available
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Summary

This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).

Conditions

  • Chronic Venous Insufficiency

Interventions

DEVICE

Venclose RF System

Treatment of great saphenous vein (GSV) using Venclose RF System

Sponsors & Collaborators

  • Venclose, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Mattausch, Dr. med · Venenzentrum am Bruehl

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2021-08-02
Completion
2021-08-02
FDA Device
Yes

Countries

  • Germany

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 NCT04236245 on ClinicalTrials.gov