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

NCT ID: NCT05193643

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2023-01-31

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

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

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

Intervention Type: DEVICE

Eligibility Criteria

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

Sponsors

Englewood Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Englewood Health

Englewood, New Jersey, United States

Countries

United States

Other Identifiers

E-22-881

Identifier Type: -

Identifier Source: org_study_id