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 has been completed.

First Received: July 27, 2007 Last Updated: February 10, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), 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. ] [ 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
1. RF Ablation: Active Comparator Treatment of venous disease with a Radiofrequency catheter.	Device: Segmental RF ablation with the ClosureFAST catheter radiofrequency catheter
2. Endovenous Laser: Active Comparator Treatment of venous disease with an Endovenous Laser catheter.	Device: Endovenous Laser laser catheter

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, Inc.

Investigators

Study Director:

Lian Cunningham, MD

VNUS Medical Technologies, Inc.

More Information

No publications provided

Responsible Party:	VNUS Medical Technologies, Inc. ( VNUS Medical Technologies, Inc )
Study ID Numbers:	CVL-06-03
Study First Received:	July 27, 2007
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00509392 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by VNUS Medical Technologies, Inc.:

Varicose veins, venous reflux, GSV disease

ClinicalTrials.gov processed this record on November 27, 2009