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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Venous Insufficiency, CVI Angiomatosis Blindness Blindness, Cortical Blue Rubber Bleb Nevus Syndrome CLOVES Syndrome Cardiovascular Diseases Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi Eye Diseases Klippel-Trenaunay Syndrome Klippel-Trenaunay-Weber Syndrome Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vascular Diseases Venous Leg Ulcers Venous Malformations Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Vascular Care Group

Darien, Connecticut, 06820, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

High Intensity Focused Ultrasound

Device

Sonablate High Intensity Focused Ultrasound system to ablate incompetent veins of the periphery

Other names: Venous ablation

Primary outcomes

Safety of Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery.

Time frame: 30 days

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.

Secondary outcomes

Short-term efficacy and technical feasibility of using the Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery

Time frame: 30 days

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.

Sponsors and collaborators

Lead sponsor

Sonablate

Industry

Collaborators

Vascular Breakthroughs, LLC
Vascular Care CT, PLLC

Registry information

Official study title

Safety of the Sonablate System for the High-Intensity Focused Ultrasound (HIFU) Ablation of Incompetent Veins of the Periphery

Acronym: HIFIVE

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2028
First posted: Oct 15, 2024
Registry last updated: Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation