Onyx™ Liquid Embolic System for Peripheral Arterial Hemorrhage
This study is testing the Onyx™ Liquid Embolic System (LES) to see if it's a safe and effective way to stop active bleeding in arteries outside of the brain and heart (peripheral vasculature). This could be for conditions like bleeding in the digestive system or from an injury. The study aims to enroll about 119 people who are at least 22 years old and have active arterial bleeding that doctors think can be treated with this system. Success in this study means that the bleeding stops and there are no major problems related to the system within 30 days after the procedure. The current status of this study is unclear.
- Study design
- This is a single-arm study, meaning all participants will receive the Onyx™ Liquid Embolic System. It plans to enroll about 119 people across up to 25 sites in the US.
- What's involved
- You would have a hospital discharge visit and a follow-up visit 30 days after the procedure. Any re-interventions will be tracked for 30 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 30 days after the procedure to check for bleeding and any major adverse events.
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Onyx™ Liquid Embolic IDE Clinical Study
At a glance
Conditions
Where it's being run
18 sites across 14 statesStudy leadership
- Osman Ahmed, MD · PRINCIPAL_INVESTIGATOR · University of Chicago
Who to contact
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What this trial measures
- Freedom from Arterial HemorrhageThrough 30 days post-index procedure
Freedom from arterial hemorrhage in all target location(s) after treatment with Onyx™ LES at the index procedure without re-embolization or any other intervention at the target location(s) due to persistent or recurrent hemorrhage through 30 days. Freedom from arterial hemorrhage where an arterial hemorrhage event is defined as a type 3 or greater BARC bleeding criteria as assessed by the Clinical Events Committee (CEC) through 30 days.
- Freedom from System-related Major Adverse Events (MAE)Through 30 days post-index procedure
The primary safety endpoint is defined as freedom from system-related Major Adverse Events (MAE) through 30 days after the point of enrollment as assessed by the CEC.