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PELE - Peripheral Onyx Liquid Embolic IDE Clinical Study

UCI Specialty Area: Emergency Services
Principal Investigator: Nadine Abi-Jaoudeh
Official Title: PELE - Peripheral Onyx Liquid Embolic IDE Clinical Study, Safety and Effectiveness of The Onyx LES for embolization of arterial hemorrhage in the Peripheral Vasculature clinical research study
A Study On:
Trauma

Study Description

This is a pivotal, prospective, multi-center, non-randomized, single arm study. This study will enroll patients with active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by investigator. In this study, peripheral vasculature is defined as outside of the brain and heart.

Up to 135 subjects will be consented to achieve 119 enrolled at up to 25 sites in the US.

This study will have two visits post-index procedure including hospital discharge visit and 30-day follow-up visit. Reintervention visits will be captured through 30 days post-index procedure.

Eligibility

  1. Patient is greater than or equal to 22 years old.
  2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.

In this study, peripheral vasculature is defined as outside the brain and heart.

  1. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
  2. Life expectancy of greater than 30 days, in the opinion of the investigator at the time of enrollment.
  3. Target treatment area is free from prior embolization treatment.
  1. Pregnant or breastfeeding.
  2. Symptoms of active infection.
  3. Patient is known to be participating in the study of an investigational drug, biologic, or device.
  4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
  5. Known allergy to components of Onyx
  6. Target vasculature unsuitable for the delivery of Onyx based upon physician assessment.
  7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
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  • You are being asked to participate in a clinical research potential participant database to identify
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  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
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What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI