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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 29, 2014