Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU)

Study Overview
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Brief Summary
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This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment. Secondary objective To assess the general safety and ablation rate outcomes following HIFU treatment of GSV

Official Title
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Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Single Center Prospective Feasibility Study

Conditions
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Great Saphenous Vein Insufficiency

Intervention / Treatment
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* Device: Sonovein Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated CEAP-clinical classification ≥ 2 Physical condition allowing ambulation after the procedure. Agree to comply with the Clinical investigation plan and follow-up schedule of the study Targeted tissue reachable for treatment with the device - meaning between 5mm and 24mm below the skin surface. Age over 22 years at the time of enrollment. No acute venous thrombosis. No complete or near complete deep vein post-thrombotic disease. Patient has signed and understood the written informed consent. Exclusion criteria Patient is pregnant Known allergic reaction to anesthetics to be used. Legally incapacitated or imprisoned patients Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit. Patient participating in another clinical trial involving an investigational drug or device. Ankle-brachial index <7 (ABI) Undergoing active anticoagulant therapy within the last 6 months Diameter of the treated anatomical segment below ≤ 2mm -

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sonovein Treatment<br> | Device: Sonovein Treatment<br>* The Sonovein System provides High Intensity Focused Ultrasound (HIFU) ablation of soft tissue. The energy is delivered via an extra-corporeal treatment probe, which includes an imaging system. The high-energy ultrasound waves propagate through the skin and are focused on a portion of the target tissue, generating intense heat and causing local cell apoptosis and progressive tissue volume reduction over the following months in the tissue within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Feasibility | Technical feasibility of the procedure in terms of the procedure technical success rate | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation of venous reflux | - Ablation of venous reflux (as measured by Duplex ultrasound) | 3 months |