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TERMINATED
NCT03820947
NA

VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Sponsor: Medtronic Endovascular

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.

PROCEDURE

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