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Sponsored by: |
VNUS Medical Technologies, Inc. |
---|---|
Information provided by: | VNUS Medical Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00509392 |
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, 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) |
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.
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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 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gary Heinemann | 408-360-7274 | gheinemann@vnus.com |
Contact: Susan Miksad | 408-360-7325 | smiksad@vnus.com |
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 |
Study Director: | Lian Cunningham, MD | VNUS Medical Technologies, Inc. |
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 |
Varicose veins, venous reflux, GSV disease |
Varicose Veins |