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Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
Sponsor: Sonablate
Summary
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the periphery meaning legs, abdomen, chest or back. Examples of CVI are varicose veins, vascular congestion, venous ulcer, venous clusters, venous anomalies, mixed malformation, Klippel-Trenaunay Syndrome, CLOVES, Syndrome, Blue Rubber bleb Nevus Syndrome. HIFU is a non-invasive treatment as opposed to current treatment options which include incisions, needle penetration, wire insertions or catheter insertions.
Official title: Safety of the Sonablate System for the High-Intensity Focused Ultrasound (HIFU) Ablation of Incompetent Veins of the Periphery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-09-11
Completion Date
2028-02
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
High Intensity focused ultrasound
Sonablate High Intensity Focused Ultrasound system to ablate incompetent veins of the periphery
Locations (1)
The Vascular Care Group
Darien, Connecticut, United States