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NCT00509392 Clinical Trial

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

Venous Reflux Clinical Trial

— RECOVERY  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00509392
Other study ID # CVL-06-03
Secondary ID
Status Completed
Phase Phase 4
First received July 27, 2007
Last updated December 11, 2009
Start date March 2007
Est. completion date January 2008

Study information
Verified date December 2009
Source VNUS Medical Technologies, A Covidien Company
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Segmental RF ablation with the ClosureFAST catheter
radiofrequency catheter
• Endovenous Laser
laser catheter

Locations
Country Name City State
United States Oregon Health Sciences Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
VNUS Medical Technologies, A Covidien Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Almeida JI, Kaufman J, Göckeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomi — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Post-procedure recovery for each treatment group; including post-procedure pain and return to normal activities. 30 days following treatment. No
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