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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Venous Reflux

Treatments: Device: Seg. RF Ablation & ClosureFAST catheter; Device: Endovenous Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509392

CVL-06-03

Details and patient eligibility

About

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.

Full description

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

Enrollment: 69 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

Seg. RF Ablation & ClosureFAST catheter

Active Comparator group

Description:

Seg. RF Ablation \& ClosureFAST catheter

Treatment:

Device: Seg. RF Ablation & ClosureFAST catheter

Endovenous Laser

Active Comparator group

Description:

Treatment invention of venous disease with an Endovenous Laser.

Treatment:

Device: Endovenous Laser