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ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study. (RECOVERY)

This study has been completed.
Sponsor:
Information provided by:
VNUS Medical Technologies, A Covidien Company
ClinicalTrials.gov Identifier:
NCT00509392
First received: July 27, 2007
Last updated: December 11, 2009
Last verified: December 2009
History of Changes
  Purpose

The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.


Condition Intervention Phase
Great Saphenous Vein Disease
Venous Reflux
 Device: Segmental RF ablation with the ClosureFAST catheter
Device: Endovenous Laser
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by VNUS Medical Technologies, A Covidien Company:

Primary Outcome Measures:
  • Post-procedure recovery for each treatment group; including post-procedure pain and return to normal activities. [ Time Frame: 30 days following treatment. ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. RF Ablation
Treatment of venous disease with a Radiofrequency catheter.
 Device: Segmental RF ablation with the ClosureFAST catheter
radiofrequency catheter
Other Name: VNUS
Active Comparator: 2. Endovenous Laser
Treatment of venous disease with an Endovenous Laser catheter.
 Device: Endovenous Laser
laser catheter
Other Name: Commercially approved laser catheter systems.

Detailed Description:

Comparison of the post-procedure recovery of radiofrequency treatment vs. laser treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects must provide written informed consent.
  • Must be a candidate for either treatment with RFA or endovenous laser.

Exclusion Criteria:

  • Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
  • Subjects who are participating in another investigational study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509392

Locations
United States, Oregon
Oregon Health Sciences
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VNUS Medical Technologies, A Covidien Company
Investigators
Study Director: Lian Cunningham, MD VNUS Medical Technologies, A Covidien Company
  More Information

Publications:

Responsible Party: VNUS Medical Technologies, Inc, VNUS Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00509392     History of Changes
Other Study ID Numbers: CVL-06-03
Study First Received: July 27, 2007
Last Updated: December 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by VNUS Medical Technologies, A Covidien Company:
Varicose veins, venous reflux, GSV disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Venous Insufficiency
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013