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

NCT05926830 | Completed FDA Device

• 1 other identifier: HIFU-VN-FDA-VEINRESET 01
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 4

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

Keywords

Varicose Vein; HIFU; Theraclion

Outcome Measures

Primary Outcomes (1)

• Vein Occlusion Rate

  Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound)

  12 months

Secondary Outcomes (4)

• Complications

  12 months

• Reflux-free Rate

  12 months

• Venous Clinical Severity Score (VCSS)

  12 months

• Clinical-Etiology-Anatomy-Pathophysiology (CEAP)

  12 months

Study Arms (1)

Sonovein Treatment

EXPERIMENTAL

Device: Sonovein Treatment

Interventions

Sonovein Treatment 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.

Sonovein Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient is pregnant
• Known allergic reaction to anesthetics to be used.
• Legally incapacitated or imprisoned patients
• 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

Sponsors & Collaborators

• Theraclion: lead

Study Sites (4)

Englewood Health

Englewood, New Jersey, 07631, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Praxis für Phlebologie

Melk, 3390, Austria

Location

Phlebomedica s.r.o

Říčany, Czechia

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 3, 2023
• Study Start: October 12, 2023
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CZ (1); AU (1)