Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery (NCT06642051) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
United States30 participantsStarted 2024-09-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Patient unable or unwilling to provide consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery.
. Patient unable or unwilling to undergo HIFU energy delivery
. Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs
. Patient with known vasculitis or other inflammatory vasculopathies
. Patients with active or prior history of DVT or PE
. 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
. Subject who has vascular tissue targets lying \<1cm from sensitive structures or large vessels
. Women who are pregnant or planning to become pregnant prior to procedure or within the 30-day study period, or nursing