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
(VEINRESET Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Eligibility Criteria
Inclusion Criteria
Treatment Details
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Who Is Running the Clinical Trial?
Theraclion
Lead Sponsor