Onyx™ Liquid Embolic IDE Clinical Study (NCT06742801) | Clinical Trial Compass
RecruitingNot Applicable
Onyx™ Liquid Embolic IDE Clinical Study
United States119 participantsStarted 2025-05-09
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.
Who can participate
Age range
22 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
. Patient is ≥ 22 years old.
. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.
. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
. Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
. Target treatment area is free from prior embolization treatment.
Exclusion criteria
. Pregnant or breastfeeding.
. Symptoms of active infection.
. Patient is known to be participating in the study of an investigational drug, biologic, or device.
. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
. Known allergy to components of Onyx™.
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
Freedom from Arterial Hemorrhage
Timeframe: Through 30 days post-index procedure
2
Freedom from System-related Major Adverse Events (MAE)