Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease
Diseases of the Cardiovascular System
What is the purpose of this trial?
VenaSeal Spectrum Study is a Post-market, Randomized Study for the treatment of early and advanced stage venous disease. The treatments offered in this study are:
1. VenaSeal™ Closure System (Study product)
Uses a medical grade adhesive to close the veins.
2. Endothermal ablation (Control Arm)
Uses heat to close the veins.
All the products that will be used in this study are approved by FDA and commercially available. None of the treatments are experimental in this study.
What is Venous Disease?
This is a medical condition which affects the blood circulation in your leg. Venous reflux disease develops when one-way valves valves stop working properly and allow blood to flow backward and pool in the lower leg veins, leading to varicose veins.
Varicose veins can cause symptoms such as heaviness, aching or throbbing pain in the lower legs, cramps, restless leg syndrome, itchiness, fatigue, swelling and tenderness along the vein.
Varicose veins can also sometimes cause wounds, or venous leg ulcers (VLU) which can cause additional pain and tenderness.
- Ages18 years and older
- Trial withMedtronic, Inc
- Start Date01/21/2021
- End Date11/30/2022
- Last Updated07/15/2021
- Study HIC#2000028013