Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT02215369
Brief 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.
Study:
NCT02215369
Study Brief:
Protocol Section:
NCT02215369