Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study
Completed · Not applicable
Conditions studied: Chronic Venous Insufficiency
In brief
This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency. Patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will receive treatment with Sonovein for the targeted segments of GSV. At follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 12 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment.
Key facts
- Study ID
- NCT05926830
- Run by
- Theraclion
- People needed
- 70
- Starts
- 2023-10-12
- Expected to finish
- 2025-06-11
- Last updated by the study team
- 2025-06-19
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit
- 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 \& above > 20mm
- Patients where HIFU cannot be delivered to tissues where macro calcifications induce a significant shadow in the ultrasonic image
- Patients where EPack must be put in contact with an ulcer
- Patients with significant thick scars on the skin over the segment to be treated
- Security distance respected in regards of :
- nerves \& bones
- the surrounding vessels
- Patient who may not be considered as good candidates for treatment by the investigator outside the explicit exclusion criteria above listed
Where it is running
- Englewood Health — Englewood, New Jersey, United States
- Northwell Health — Lake Success, New York, United States
- Praxis für Phlebologie — Melk, Austria
- Phlebomedica s.r.o — Říčany, Czechia
Full record on ClinicalTrials.gov
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