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
- Conditions
- Chronic Venous Insufficiency
- Interventions
- Device: Sonovein Treatment
- Registration Number
- NCT05926830
- Lead Sponsor
- Theraclion
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
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Patient is pregnant
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Known allergic reaction to anesthetics to be used.
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Legally incapacitated or imprisoned patients
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Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit
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Patient participating in another clinical trial involving an investigational drug or device.
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Ankle-brachial index <7 (ABI)
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Undergoing active anticoagulant therapy within the last 6 months
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Diameter of the treated anatomical segment below ≤ 2mm & above > 20mm
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Patients where HIFU cannot be delivered to tissues where macro calcifications induce a significant shadow in the ultrasonic image
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Patients where EPack must be put in contact with an ulcer
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Patients with significant thick scars on the skin over the segment to be treated
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Security distance respected in regards of :
- nerves & bones
- the surrounding vessels
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Patient who may not be considered as good candidates for treatment by the investigator outside the explicit exclusion criteria above listed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sonovein Treatment Sonovein Treatment -
- Primary Outcome Measures
Name Time Method Vein Occlusion Rate 12 months Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound)
- Secondary Outcome Measures
Name Time Method Clinical-Etiology-Anatomy-Pathophysiology (CEAP) 12 months Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Venous Clinical Severity Score (VCSS) 12 months Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Complications 12 months Number of limbs presenting complications and side effects resulting from the GSV intervention
Reflux-free Rate 12 months Percentage of limbs without reflux in the treated vein (as measured by Duplex ultrasound)
Trial Locations
- Locations (4)
Phlebomedica s.r.o
🇨🇿Říčany, Czechia
Northwell Health
🇺🇸Lake Success, New York, United States
Praxis für Phlebologie
🇦🇹Melk, Austria
Englewood Health
🇺🇸Englewood, New Jersey, United States