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EchoTip AcuCore EUS Biopsy Needle Post-Market Study

UCI Specialty Area: Other
Principal Investigator: Jason Samarasena
Official Title: EchoTip AcuCore EUS Biopsy Needle Post-Market Study
A Study On:
Other

Study Description

Eligibility

  1. Patient has been referred for an endoscopic ultrasound (EUS) fine needle biopsy procedure
  2. The EchoTip AcuCore device is the first EUS biopsy needle used in the procedure.
  1. Patient's age is less than 18 years
  2. Patient is unable or unwilling to sign and date the informed consent. If IRB approves a waiver of consent, this exclusion criterion is not applicable.
  3. Patient is simultaneously participating in another pre-market investigational drug or pre-market investigational device study involving an EUS fine needle biopsy procedure and for which the patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment in this study.
  4. Inaccessible or unsuitable lesion (lesion not visualized or a large vessel, duct or primary mass interposition)
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Privacy Policy

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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  • 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.
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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.