Study of BD ORC Original Absorbable Hemostat Compared with Surgicel® Original Absorbable Hemostat
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StatusAccepting Candidates
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Age22 Years - 101 Years
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SexesAll
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Healthy Volunteers
Description
The purpose of this study is to evaluate the safety and efficacy of BD ORC Original Absorbable Hemostat when compared to a currently marketed ORC hemostat (Surgicel® Original Absorbable Hemostat) for achieving hemostasis at target bleeding sites (TBSs) as an adjunctive hemostat in planned, open/minimally invasive procedures.
Details
Protocol number | DVL-HEM-001 |
Eligibility
Inclusion criteria:
- 22 years of age or older at the time of consent
- Undergoing a planned open/minimally invasive surgical procedure (urology)
- Agrees to comply with all study procedures and to be available for the duration of the study
- Provision of signed and dated informed consent form
Exclusion Criteria:
- ASA Class IV Score or Higher
- Pregnant or plans to become pregnant during the study period
- Has an uncontrolled bleeding disorder
- Has a documented clinical history of bleeding or coagulation disorder or disease
- Has taken exclusionary concomitant medications (blood thinners or chronic steroids)
- Has a known or suspected hypersensitivity to oxidized cellulose or ORC
Lead researcher
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Kethandapatti Balaji, MBBS, FRCS, MRCS, LRCPUrologist
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
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
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Step2
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.
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Step3
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.
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Step4
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.