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

Englewood Hospital and Medical Center

Status: Completed

Conditions: Great Saphenous Vein Insufficiency

Treatments: Device: Sonovein Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05193643

E-22-881

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Sonovein Treatment

Experimental group

Treatment:

Device: Sonovein Treatment