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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-01-31

Brief Summary

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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

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

Conditions

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Venous Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Seg. RF Ablation & ClosureFAST catheter

Seg. RF Ablation \& ClosureFAST catheter

Group Type ACTIVE_COMPARATOR

Seg. RF Ablation & ClosureFAST catheter

Intervention Type DEVICE

Seg. RF Ablation \& ClosureFAST catheter

Endovenous Laser

Treatment invention of venous disease with an Endovenous Laser.

Group Type ACTIVE_COMPARATOR

Endovenous Laser

Intervention Type DEVICE

laser catheter

Interventions

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Seg. RF Ablation & ClosureFAST catheter

Seg. RF Ablation \& ClosureFAST catheter

Intervention Type DEVICE

Endovenous Laser

laser catheter

Intervention Type DEVICE

Other Intervention Names

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VNUS Commercially approved laser catheter systems.

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No