Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study

Study Overview
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Brief Summary
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This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency. Patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will receive treatment with Sonovein for the targeted segments of GSV. At follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 12 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment.

Official Title
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Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study (VEINRESET)

Conditions
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Chronic Venous 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. 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 & above > 20mm Patients where HIFU cannot be delivered to tissues where macro calcifications induce a significant shadow in the ultrasonic image Patients where EPack must be put in contact with an ulcer Patients with significant thick scars on the skin over the segment to be treated Security distance respected in regards of : nerves & bones the surrounding vessels Patient who may not be considered as good candidates for treatment by the investigator outside the explicit exclusion criteria above listed

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. The process is then repeated in a stepwise fashion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Number of limbs presenting complications and side effects resulting from the GSV intervention | 12 months | 
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein (as measured by Duplex ultrasound) | 12 months | 
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 12 months | 
| Clinical-Etiology-Anatomy-Pathophysiology (CEAP) | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose Vein, HIFU, Theraclion