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CraniSeal Post Approval Study

Study on CraniSeal's effectiveness after approval.

Recruiting
18 years and older
All
Phase 4
**CraniSeal Post Approval Study** This study looks at how safe and effective the CraniSeal Dural Sealant is compared to another product called DuraSeal. Both are used during brain surgery to help close the dura, a protective layer around the brain. Researchers want to see if people using CraniSeal have less risk of cerebrospinal fluid (CSF) leaks after surgery. They will also check for infections or other issues caused by the sealant. To join, you must be 18 or older and need a specific type of brain surgery. You shouldn't have certain health problems like kidney or liver issues, or be pregnant. Some brain surgeries, previous surgeries in the same spot, or other conditions might exclude you. You also cannot join if you are in another medical trial. **Key Points:** - **Length of Study:** Participants will need to comply with follow-up evaluations. - **Eligibility:** Must be scheduled for certain types of brain surgeries and meet health criteria. - **Risks:** Possible surgical site infections and other adverse events will be monitored. This study helps ensure that new medical devices work well and are safe for patients.
Study details
    Leak
    Cerebrospinal Fluid

NCT06406790

Pramand LLC

7 March 2026

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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