Using High Intensity Focused Ultrasound to Treat Incompetent Veins

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

This study is testing a new non-invasive ultrasound treatment for people with chronic venous insufficiency to see if it safely helps fix problem veins without surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sonablate (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Darien, Connecticut)
• Trial ID: NCT06642051 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and technical feasibility of the Sonablate High Intensity Focused Ultrasound (HIFU) system for treating patients with Chronic Venous Insufficiency (CVI) and related venous malformations. The study will involve 30 adult patients who will receive non-invasive HIFU treatment to ablate incompetent veins located in the legs, abdomen, chest, or back. The primary focus is to assess the 30-day safety profile of this innovative approach, which avoids traditional invasive methods like incisions or catheter insertions. The trial is set to last 18 months and will be conducted at a single institution.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with venous malformations or insufficiency located no deeper than 4.0 cm from the skin surface.

Not a fit: Patients with vascular lesions in the central nervous system, face, head, neck, or those with active or prior history of deep vein thrombosis or pulmonary embolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer, non-invasive option for patients suffering from chronic venous conditions.

How similar studies have performed: While the use of HIFU for other applications has shown promise, this specific application for venous conditions is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Darien, Connecticut

• The Vascular Care Group — Darien, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Naiem Nassiri, MD, FSVS, RPVI — The Vascular Care Group
• Study coordinator: Clinical Research Nurse Coordinator

Conditions: Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome, CLOVES Syndrome, Blue Rubber Bleb Nevus Syndrome, High Intensity focused ultrasound, venous closure