An interventional study of High Intensity focused ultrasound in Chronic Venous Insufficiency, CVI, Venous Malformations and Venous Leg Ulcers, sponsored by Sonablate. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Sonablate · Not applicable, Interventional, and Treatment
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.
8 studies on the registry are indexed under Klippel-Trenaunay-Weber Syndrome; 4 are open to participants now.
Browse Klippel-Trenaunay-Weber Syndrome studies →Sonablate is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients that have undergone high intensity focused ultrasound ablation of incompetent veins of the periphery
Device: High Intensity focused ultrasound
Sonablate High Intensity Focused Ultrasound system to ablate incompetent veins of the periphery
Also known as: Venous ablation
Safety of Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery.
Safety as measured by the magnitude and frequency of adverse events from HIFU. This includes any burns, scalds, blistering and hyperemic changes on physical exam intraoperatively, at 6h, 24h, 1w, and 4 weeks post-operatively; worsening limb pain and swelling due to DVT diagnosed with Duplex Ultrasound within 4 weeks post-operatively; sensory nerve injury via formal neurological examination at 6h, 1w, and 4 weeks post-operatively.
Time frame: 30 days
Short-term efficacy and technical feasibility of using the Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery
Real-time B mode ultrasound imaging of HIFU to vascular tissue to evaluate the ultrasonographic changes in the targeted vessels and immediately adjacent tissues. Intraoperative duplex ultrasound of the targeted veins to quantify vessel closure rates or thrombosis immediately after HIFU delivery. Post-operative duplex ultrasound or magnetic resonance imaging of the targeted veins during follow up at 1 week and 4 weeks to assess vessel closure rates or thrombosis of target veins.
Time frame: 30 days
Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for Sep 2027, 36 months after the start.
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This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Klippel-Trenaunay-Weber Syndrome →
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