Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery (HIFIVE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Venous Leg Ulcers; Venous Malformations; CLOVES Syndrome; Blue Rubber Bleb Nevus Syndrome; Klippel-Trenaunay Syndrome; Chronic Venous Insufficiency, CVI
• Intervention / Treatment: Device: High Intensity focused ultrasound

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • The Vascular Care Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective observational; 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; Other Names: Venous ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: Sonablate
• Collaborators: Vascular Care CT, PLLC; Vascular Breakthroughs, LLC
• Investigators: Principal Investigator: Naiem Nassiri, MD, FSVS, RPVI, The Vascular Care Group

Publications and helpful links

Helpful Links

• Vascular anomalies and malformation program patient information website
• Resource for information on vascular birthmarks, anomalies and related symptoms.
• Comprehensive online information on the Sonablate high intensity focused ultrasound probe.
• Comprehensive source of information for vast array of clinical applications for focused ultrasound therapy

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: endovenous ablation; High Intensity focused ultrasound; venous closure
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Blindness; Angiomatosis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Klippel-Trenaunay-Weber Syndrome; Blindness, Cortical; Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi; Blue rubber bleb nevus syndrome
• Other Study ID Numbers: 20243482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes