Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery

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.

NCT Number	NCT06642051
Lead Sponsor	Sonablate Collaborators: Vascular Care CT, PLLC, Vascular Breakthroughs, LLC
Conditions	Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome, CLOVES Syndrome, Blue Rubber Bleb Nevus Syndrome
Enrollment	30 participants
Start Date	2024-09-11
Primary Completion	2027-09 (estimated)
Study Completion	2028-02 (estimated)
Updated on ClinicalTrials.gov	2026-02-19