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

NCT05193643 | Completed FDA Device

• 1 other identifier: E-22-881
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Great Saphenous Vein Insufficiency

Outcome Measures

Primary Outcomes (1)

• Technical Feasibility

  Technical feasibility of the procedure in terms of the procedure technical success rate

  3 months

Secondary Outcomes (1)

• Ablation of venous reflux

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

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 - meaning between 5mm and 24mm below the skin surface.
• 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

Sponsors & Collaborators

• Englewood Hospital and Medical Center: lead

Study Sites (1)

Englewood Health

Englewood, New Jersey, 07631, United States

Location

Study Design

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

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: March 23, 2022
• Primary Completion: October 8, 2022
• Study Completion: January 31, 2023
• Last Updated: April 19, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)