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

Running, not enrolling · Not applicable

Conditions studied: Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome, CLOVES Syndrome, Blue Rubber Bleb Nevus Syndrome

In brief

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.

Key facts

Study ID

NCT06642051

Run by

Sonablate

People needed

30

Starts

2024-09-11

Expected to finish

2028-02-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients of age 18 or older with clinical and imaging evidence of venous malformations and/or venous insufficiency of the periphery
• Lesions no deeper than 4.0cm from the skin surface
• Lesions appropriate for and patient amenable to HIFU therapy of targeted vascular lesion/structure as determined by the principal operator and investigator
• Ability to provide treatment consent for Sonablate HIFU energy delivery
• Ability and willingness to remain compliant with recommended post-op follow-up

You may not qualify if…

• Patient unable or unwilling to provide consent
• Patient unable or unwilling to undergo HIFU energy delivery
• Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs
• Patient with known vasculitis or other inflammatory vasculopathies
• Patients with active or prior history of DVT or PE
• Any lesion deemed unsafe by the treating surgeon or PI of the study for HIFU at the time of treatment based on clinical assessment, ultrasonographic features and/or probe positioning limitations
• Subject who has vascular tissue targets lying \<1cm from sensitive structures or large vessels
• Women who are pregnant or planning to become pregnant prior to procedure or within the 30-day study period, or nursing
• Vulnerable patients
• Subject with vessels \>6 mm in diameter within the vascular tissue target

Where it is running

• The Vascular Care Group — Darien, Connecticut, United States

Full record on ClinicalTrials.gov

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