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Study of BD ORC Original Absorbable Hemostat vs. Surgicel庐 Original Absorbable Hemostat

  • Status
    Accepting Candidates
  • Age
    22 Years - 99 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

This study will evaluate the safety and efficacy of BD ORC Original Absorbable Hemostat when compared to a currently marketed ORC hemostat (Surgicel庐 Original Absorbable Hemostat) for achieving hemostasis at target bleeding sites (TBSs) as an adjunctive hemostat in planned, open/minimally invasive general surgical procedures

Details

Protocol number DVL-HEM-001

Eligibility

Inclusion Criteria:

  1. Males or females 22 years of age or older at the time of consent
  2. Is undergoing a planned open/minimally invasive surgical procedure in general surgery

Exclusion Criteria:

  1. Is known to be pregnant or plans to become pregnant during the study period
  2. Has an uncontrolled bleeding disorder
  3. Has a documented clinical history of bleeding or coagulation disorder or disease

  4. Has received hemodialysis within 30 days before surgery or is planned to receive hemodialysis within 45 days post-surgery

  5. Has documented severe congenital or acquired immunodeficiency or is currently being treated with immunosuppressive drugs

  6. Has been treated or is planning to be treated with another investigational drug or device within 30 days of surgery

  7. Has taken blood thinners or chronic steroids

Lead researchers

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.