Phase 4
Completed N=69
ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.
Venous Reflux
Source: ClinicalTrials.gov NCT00509392 ↗
Enrolled (actual)
69
Serious AEs
1.2%
Results posted
Jul 2017
Primary outcomePrimary: Pain — 0.7; 1.9 units on a scale — p=<0.0001
◆ Published Evidence
Highly cited
287citations · ~17 / year
Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
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.
Linked Publications
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Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
0.2; 0.4 | 0.2962 |
| PRIMARY Tenderness |
0.3; 0.5 | 0.5761 |
| PRIMARY Ecchymosis |
45; 31; 1; 9; 0; 0 | 0.0050 sig |
| PRIMARY Complications |
1; 0; 0; 8; 2; 3 | — |
| SECONDARY VCSS |
2.7; 3.2 | 0.2825 |
| SECONDARY Change in CIVIQ QOL |
-17.8; -17.5 | 0.9463 |
Eligibility Criteria
Inclusion Criteria
- All subjects must provide written informed consent.
- Must be a candidate for either treatment with Radiofrequency Ablation (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.
Data sourced from ClinicalTrials.gov (NCT00509392) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.