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

NCT ID: NCT05926830

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2025-06-11

Brief Summary

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.

Conditions

Chronic Venous Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sonovein Treatment

Group Type: EXPERIMENTAL

Sonovein Treatment

Intervention Type: DEVICE

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.

Interventions

Sonovein Treatment

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theraclion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Englewood Health

Englewood, New Jersey, United States

Northwell Health

Lake Success, New York, United States

Praxis für Phlebologie

Melk, , Austria

Phlebomedica s.r.o

Říčany, , Czechia

Countries

United States; Austria; Czechia

Other Identifiers

HIFU-VN-FDA-VEINRESET 01

Identifier Type: -

Identifier Source: org_study_id