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Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein

NCT01173419 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-07-13

No results posted yet for this study

Summary

This is a multi center, randomized, comparison study using two already cleared methods of treatment of the great saphenous vein (GSV). The hypothesis to be tested is that the use of the Venacure EVLT NeverTouch procedure is no worse than the RF ClosureFAST procedure for treatment of the GSV. Evaluation of post operative pain and bruising, quality of life assessments, adverse event assessments, confirmation of long term GSV closure, use of medications are criteria that will be evaluated during the course of this study.

Conditions

  • Varicose Veins
  • Venous Insufficiency

Interventions

DEVICE

VNUS RF ClosureFAST

VNUS® RF ClosureFAST is a minimally invasive varicose vein treatment procedure that uses radiofrequency energy (electricity) to heat, collapse and seal off the targeted blood vessels.

DEVICE

VenaCure EVLT NeverTouch

Endovenous Laser Treatment (EVLT) uses laser energy, which is a highly concentrated beam of light to treat varicose veins.

Sponsors & Collaborators

  • Angiodynamics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Gillespie, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-02-28
Completion
2012-02-29

Countries

  • United States

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 NCT01173419 on ClinicalTrials.gov