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

Safety of the Sonablate System for the High-Intensity Focused Ultrasound (HIFU) 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.

The Sonablate High Intensity Focused Ultrasound (HIFU) system is a non-invasive technology that uses focused ultrasound waves to ablate targeted tissue within the body without ionizing radiation or surgical excision. Through the precise delivery of ultrasonic waves, HIFU rapidly elevates the temperature in the targeted tissue, leading to the disruption of lipid membranes, denaturation of proteins, destruction of vascular endothelial cells and ultimately coagulative necrosis without damage to the overlying tissue. This device is cleared by the FDA for the ablation of prostate tissue.

This is a single arm, single institution, Phase one trial of 30 patients planned to last 18 months. The primary endpoint is to assess the 30-day safety profile and technical feasibility of using the Sonablate high-intensity focused ultrasound (HIFU) system for ablating incompetent veins of the periphery. This includes vascular malformations, varicose veins and incompetent superficial veins.

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient unable or unwilling to provide consent
2. Patient unable or unwilling to undergo HIFU energy delivery
3. Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs
4. Patient with known vasculitis or other inflammatory vasculopathies
5. Patients with active or prior history of DVT or PE
6. 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
7. Subject who has vascular tissue targets lying <1cm from sensitive structures or large vessels
8. Women who are pregnant or planning to become pregnant prior to procedure or within the 30-day study period, or nursing
9. Vulnerable patients
10. Subject with vessels >6 mm in diameter within the vascular tissue target