RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-11
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06642051

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patients of age 18 or older with clinical and imaging evidence of venous malformations and/or venous insufficiency of the periphery
  2. 2. Lesions no deeper than 4.0cm from the skin surface
  3. 3. Lesions appropriate for and patient amenable to HIFU therapy of targeted vascular lesion/structure as determined by the principal operator and investigator
  4. 4. Ability to provide treatment consent for Sonablate HIFU energy delivery
  5. 5. Ability and willingness to remain compliant with recommended post-op follow-up
  1. 1. Patient unable or unwilling to provide consent
  2. 2. Patient unable or unwilling to undergo HIFU energy delivery
  3. 3. Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs
  4. 4. Patient with known vasculitis or other inflammatory vasculopathies
  5. 5. Patients with active or prior history of DVT or PE
  6. 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. 7. Subject who has vascular tissue targets lying \<1cm from sensitive structures or large vessels
  8. 8. Women who are pregnant or planning to become pregnant prior to procedure or within the 30-day study period, or nursing
  9. 9. Vulnerable patients
  10. 10. Subject with vessels \>6 mm in diameter within the vascular tissue target

Contacts and Locations

Study Contact

Clinical Research Nurse Coordinator
CONTACT
203-548-7860
mmyslinski@vascularbreakthroughs.com
Vice President Clinical Research, Vascular Breakthroughs, LLC
CONTACT
203-548-7860
egagne@vascularbreakthroughs.com

Principal Investigator

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

Study Locations (Sites)

The Vascular Care Group
Darien, Connecticut, 06820
United States

Collaborators and Investigators

Sponsor: Sonablate

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11
Study Completion Date2026-02

Study Record Updates

Study Start Date2024-09-11
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • High Intensity focused ultrasound
  • venous closure
  • endovenous ablation

Additional Relevant MeSH Terms

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