NCT01079598

RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study

A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that patients will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator veins (IPVs).

Detailed description

The purpose of this study is to demonstrate that patients who have competent great saphenous vein (GSV) and short saphenous vein (SSV) or have undergone prior successful endovenous treatment of an incompetent GSV and/or SSV but continue to demonstrate clinical symptoms of peripheral venous insufficiency resulting from incompetent perforator veins (IPVs) will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of IPVs veins.

Conditions

• Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	RF Ablation (ClosureRFS Stylet)	Bipolar energy radiofrequency ablation with RFS stylet

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-03-03
• Last updated: 2017-05-05
• Results posted: 2017-05-05

Locations

3 sites across 1 country: United States