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VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Sponsor: Medtronic Endovascular
Summary
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
Official title: 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 & Advanced Stage Superficial Venous Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
506
Start Date
2020-02-05
Completion Date
2025-11-10
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
VenaSeal™ System
The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Endothermal Ablation (ETA)
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Surgical Stripping
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
Locations (32)
Yavapai Regional Medical Center
Prescott Valley, Arizona, United States
PIMA Heart and Vascular
Tucson, Arizona, United States
Valley Vascular Surgical Associates
Fresno, California, United States
Vascular Care Connecticut
Darien, Connecticut, United States
Yale School of Medicine
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Vascular Care Group
Wellesley, Massachusetts, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Orion Medical
Houston, Texas, United States
Lake Washington Vascular
Bellevue, Washington, United States
Sunshine Coast University Hospital
Birtinya, Australia
Wollongong Hospital
Wollongong, Australia
East Toronto Vascular Clinic
Toronto, Ontario, Canada
CHU Dijon Bourgogne
Dijon, DIjon Cedex, France
Clinique du Parc
Lyon, France
Clinique Pasteur
Toulouse, France
Praxis fur Innere Medizin und Gefäβkrankheiten
Halle, Germany
Ospedale Fatebenefratelli e Oftalmico
Milan, Italy
Azienda Ospedaliera di Padova Ospendale Sant' Antonio
Padova, Italy
Rijnstate - Locatie Arnhem
Arnhem, Netherlands
Seoul National University Hospital
Seoul, South Korea
Seoul Saint Mary's Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)
Granada, Spain
Sanitas Hospital Universitario La Zarzuela
Madrid, Spain
Bedfordshire Hospitals NHS Foundation Trust
Bedford, United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, United Kingdom
West London Vascular and Interventional Centre
Harrow, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, United Kingdom