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| Descriptive Information Fields | |||||||||
| Brief Title † | ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study. | ||||||||
| Official Title † | 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Post-procedure recovery for each treatment group; including post-procedure pain and return to normal activities. [ Time Frame: 30 days following treatment. ] | ||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Great Saphenous Vein Disease Venous Reflux |
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| Intervention † | Device: Segmental RF ablation with the ClosureFAST catheter Device: Endovenous Laser |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 100 | ||||||||
| Start Date † | March 2007 | ||||||||
| Completion Date | November 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00509392 | ||||||||
| Organization ID | CVL-06-03 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | VNUS Medical Technologies, Inc. | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | VNUS Medical Technologies, Inc. | ||||||||
| Verification Date | July 2007 | ||||||||
| First Received Date † | July 27, 2007 | ||||||||
| Last Updated Date | July 27, 2007 | ||||||||
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