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

NCT06642051 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 20243482
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

High Intensity focused ultrasound; venous closure; endovenous ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  30 days

Study Arms (1)

Prospective observational

EXPERIMENTAL

Patients that have undergone high intensity focused ultrasound ablation of incompetent veins of the periphery

Device: High Intensity focused ultrasound

Interventions

High Intensity focused ultrasound DEVICE

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

Also known as: Venous ablation

Prospective observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sonablate: lead
• Vascular Care CT, PLLC: collaborator
• Vascular Breakthroughs, LLC: collaborator

Study Sites (1)

The Vascular Care Group

Darien, Connecticut, 06820, United States

Location

Related 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

MeSH Terms

Conditions

Blindness, Cortical; Klippel-Trenaunay-Weber Syndrome; Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi; Blue rubber bleb nevus syndrome

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Angiomatosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Naiem Nassiri, MD, FSVS, RPVI

  The Vascular Care Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The use of High Intensity Focused Ultrasound for the ablation of incompetent veins of the periphery.

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: October 15, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)