ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study. - Full Text View

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

This study is currently recruiting participants.

Verified by VNUS Medical Technologies, Inc., July 2007

Sponsored by:	VNUS Medical Technologies, Inc.
Information provided by:	VNUS Medical Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00509392

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)

Further study details as provided by VNUS Medical Technologies, Inc.:

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. ]

Estimated Enrollment:	100
Study Start Date:	March 2007
Estimated Study Completion Date:	November 2007

Arms	Assigned Interventions
1. RF Ablation: Active Comparator Treatment of venous disease with a Radiofrequency catheter.	Device: Segmental RF ablation with the ClosureFAST catheter
2. Endovenous Laser: Active Comparator Treatment of venous disease with an Endovenous Laser catheter.	Device: Endovenous Laser

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

Contacts

Contact: Gary Heinemann	408-360-7274	gheinemann@vnus.com
Contact: Susan Miksad	408-360-7325	smiksad@vnus.com

Locations

United States, Oregon
Oregon Health Sciences	Recruiting
Portland, Oregon, United States, 97239
Contact: Lori L. Watson, RN watsonlo@ohsu.edu
Principal Investigator: John Kaufman, MD

Sponsors and Collaborators

VNUS Medical Technologies, Inc.

Investigators

Study Director:

Lian Cunningham, MD

VNUS Medical Technologies, Inc.

More Information

Study ID Numbers:	CVL-06-03
Study First Received:	July 27, 2007
Last Updated:	July 27, 2007
ClinicalTrials.gov Identifier:	NCT00509392
Health Authority:	United States: Institutional Review Board

Keywords provided by VNUS Medical Technologies, Inc.:

Varicose veins, venous reflux, GSV disease

Study placed in the following topic categories:

Varicose Veins

ClinicalTrials.gov processed this record on January 16, 2009