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)

Theraclion

Status: Completed

Conditions: Chronic Venous Insufficiency

Treatments: Device: Sonovein Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05926830

HIFU-VN-FDA-VEINRESET 01

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Sonovein Treatment

Experimental group

Treatment:

Device: Sonovein Treatment