NCT02215369

SeCure Endovenous Laser Treatment Study

Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Angiodynamics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose veins. AngioDynamics, Inc., the company that manufacturers the VenaCure device, is sponsoring this study to assess the safety and effectiveness of the VenaCure EndoVenous Laser Treatment (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins (IPVs). The VenaCure EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics for the ablation of IPVs.

Detailed description

This is a single-arm, prospective, multicenter, non-blinded clinical trial. Study data will be summarized and submitted to the FDA in a premarket notification once all treated subjects have completed the 3 month visit. Longer term followup is being performed for publication purposes. Patients diagnosed with incompetent Perforator Veins (IPV's) and meet all inclusion and none of the exclusion criteria will be eligible for this study.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	VenaCure EVLT 400 µm fiber Procedure Kit	The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-03-01
• Completion: 2019-01-14
• First posted: 2014-08-13
• Last updated: 2020-05-19
• Results posted: 2020-04-21

Locations

7 sites across 1 country: United States