SeCure Endovenous Laser Treatment Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02215369
Study type	Interventional
Source	Angiodynamics, Inc.
Contact
Status	Completed
Phase	N/A
Start date	January 2015
Completion date	January 14, 2019

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SeCure Endovenous Laser Treatment Study — SeCure

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms