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

Not Applicable

Completed

• Conditions: Great Saphenous Vein Insufficiency
• Interventions: Device: Sonovein Treatment

• Registration Number: NCT05193643
• Lead Sponsor: Englewood Hospital and Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-18
• Study Start: 2022-03-23
• Status Verified: 2022-07
• Primary Completion: 2022-10-08
• Study Completion: 2023-01-31
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sonovein Treatment	Sonovein Treatment	-

Primary Outcome Measures

Name	Time	Method
Technical Feasibility	3 months	Technical feasibility of the procedure in terms of the procedure technical success rate

Secondary Outcome Measures

Name	Time	Method
Ablation of venous reflux	3 months	- Ablation of venous reflux (as measured by Duplex ultrasound)

Trial Locations

Locations (1)

Englewood Health; 🇺🇸 Englewood, New Jersey, United States