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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Device: Sonovein Treatment

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Melk, Austria, 3390
    • Praxis für Phlebologie
• Czechia
  • Říčany, Czechia
    • Phlebomedica s.r.o
• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Health
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sonovein Treatment

Device: 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.

What is the study measuring?

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
Venous Clinical Severity Score (VCSS)	Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))	12 months
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
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

Collaborators and Investigators

• Sponsor: Theraclion

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): June 11, 2025
• Study Completion (Actual): June 11, 2025

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: HIFU; Varicose Vein; Theraclion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency
• Other Study ID Numbers: HIFU-VN-FDA-VEINRESET 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No