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

Last updated: February 17, 2026
Sponsor: Sonablate
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Venous Thrombosis

Vascular Diseases

Varicose Veins

Treatment

High Intensity focused ultrasound

Clinical Study ID

NCT06642051
20243482
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients of age 18 or older with clinical and imaging evidence of venousmalformations 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 vascularlesion/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

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, andneck, 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 thetime of treatment based on clinical assessment, ultrasonographic features and/orprobe positioning limitations

  7. Subject who has vascular tissue targets lying <1cm from sensitive structures orlarge vessels

  8. Women who are pregnant or planning to become pregnant prior to procedure or withinthe 30-day study period, or nursing

  9. Vulnerable patients

  10. Subject with vessels >6 mm in diameter within the vascular tissue target

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: High Intensity focused ultrasound
Phase:
Study Start date:
September 11, 2024
Estimated Completion Date:
February 29, 2028

Study 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.

Connect with a study center

  • The Vascular Care Group

    Darien, Connecticut 06820
    United States

    Site Not Available

  • The Vascular Care Group

    Darien 4832425, Connecticut 4831725 06820
    United States

    Site Not Available

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