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First received: June 14, 2023

Clinical Trial: 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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Chronic Venous Insufficiency

Study Type: INTERVENTIONAL


Official Title: 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 Piv

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…

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