Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU)

Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Single Center Prospective Feasibility Study

This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment.

Secondary objective To assess the general safety and ablation rate outcomes following HIFU treatment of GSV

Study Overview

• Status: Completed
• Conditions: Great Saphenous Vein Insufficiency
• Intervention / Treatment: Device: Sonovein Treatment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated
2. CEAP-clinical classification ≥ 2
3. Physical condition allowing ambulation after the procedure.
4. Agree to comply with the Clinical investigation plan and follow-up schedule of the study
5. Targeted tissue reachable for treatment with the device - meaning between 5mm and 24mm below the skin surface.
6. Age over 22 years at the time of enrollment.
7. No acute venous thrombosis.
8. No complete or near complete deep vein post-thrombotic disease.
9. Patient has signed and understood the written informed consent.

Exclusion criteria

1. Patient is pregnant
2. Known allergic reaction to anesthetics to be used.
3. Legally incapacitated or imprisoned patients
4. Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
5. Patient participating in another clinical trial involving an investigational drug or device.
6. Ankle-brachial index <7 (ABI)
7. Undergoing active anticoagulant therapy within the last 6 months

8. Diameter of the treated anatomical segment below ≤ 2mm

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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 within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Feasibility	Technical feasibility of the procedure in terms of the procedure technical success rate	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ablation of venous reflux	- Ablation of venous reflux (as measured by Duplex ultrasound)	3 months

Collaborators and Investigators

• Sponsor: Englewood Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): October 8, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: E-22-881

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