HIFU for Chronic Venous Insufficiency
(HIFIVE Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment Sonablate HIFU System for Chronic Venous Insufficiency?
How does the Sonablate HIFU System treatment differ from other treatments for chronic venous insufficiency?
The Sonablate HIFU System is unique because it uses high-intensity focused ultrasound (HIFU) to non-invasively treat chronic venous insufficiency by targeting and occluding incompetent veins, unlike traditional invasive methods like vein stripping. This approach allows for precise thermal damage to the vein walls, potentially restoring function without the need for surgery.23467
Research Team
Naiem Nassiri, MD, FSVS, RPVI
Principal Investigator
The Vascular Care Group
Eligibility Criteria
This trial is for individuals with Chronic Venous Incompetence (CVI) and related conditions like varicose veins, venous ulcers, and certain syndromes affecting veins. It's open to those who have not had success with or are seeking alternatives to more invasive treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo high-intensity focused ultrasound (HIFU) ablation of incompetent veins of the periphery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at 6 hours, 24 hours, 1 week, and 4 weeks post-operatively
Treatment Details
Interventions
- Sonablate HIFU System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sonablate
Lead Sponsor
Vascular Care CT, PLLC
Collaborator
Vascular Breakthroughs, LLC
Collaborator