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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Chronic Venous Insufficiency, CVI
Intervention / Treatment

-

Contacts and Locations

Darien

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sonablate,

Naiem Nassiri, MD, FSVS, RPVI, PRINCIPAL_INVESTIGATOR, The Vascular Care Group

Study Record Dates

2026-02