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

Tracking Information

First Received Date ^ICMJE

July 27, 2007

Last Updated Date

February 10, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Post-procedure recovery for each treatment group; including post-procedure pain and return to normal activities. [ Time Frame: 30 days following treatment. ]

Change History

Complete list of historical versions of study NCT00509392 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)

Brief Summary

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.

Detailed Description

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Great Saphenous Vein Disease
Venous Reflux

Intervention ^ICMJE

Device: Segmental RF ablation with the ClosureFAST catheter
Device: Endovenous Laser

Study Arms / Comparison Groups

Active Comparator: Treatment of venous disease with a Radiofrequency catheter.
Active Comparator: Treatment of venous disease with an Endovenous Laser catheter.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00509392

Responsible Party

VNUS Medical Technologies, Inc, VNUS Medical Technologies, Inc.

Study ID Numbers ^ICMJE

CVL-06-03

Study Sponsor ^ICMJE

VNUS Medical Technologies, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Lian Cunningham, MD

VNUS Medical Technologies, Inc.

Information Provided By

VNUS Medical Technologies, Inc.

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP