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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
The Vascular Care Group
RECRUITING
Darien
Contact Information
Primary
Clinical Research Nurse Coordinator
mmyslinski@vascularbreakthroughs.com
203-548-7860
Backup
Vice President Clinical Research, Vascular Breakthroughs, LLC
egagne@vascularbreakthroughs.com
203-548-7860
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2026-02
Participants
Target number of participants: 30
Treatments
Experimental: Prospective observational
Patients that have undergone high intensity focused ultrasound ablation of incompetent veins of the periphery
Sponsors
Leads: Sonablate
Collaborators: Vascular Care CT, PLLC, Vascular Breakthroughs, LLC

This content was sourced from clinicaltrials.gov