Great Saphenous Vein Insufficiency
Conditions
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
Interventions
DEVICESonovein 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.
Sponsors
Englewood Hospital and Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Feasibility | 3 months | Technical feasibility of the procedure in terms of the procedure technical success rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ablation of venous reflux | 3 months | \- Ablation of venous reflux (as measured by Duplex ultrasound) |
Countries
United States
Outcome results
None listed