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VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

NCT03820947 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2025-12-30

Study results available
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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

Conditions

  • Venous Reflux

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.

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Kathleen Gibson, MD · Lake Washington Vascular, US

  • Manjit Gohel, MD · Addenbrooke's Hospital, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2024-06-12
Completion
2025-11-10
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03820947 on ClinicalTrials.gov