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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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CraniSeal Registry New Enrollment PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P220014 / PAS001
Date Original Protocol Accepted 12/23/2023
Date Current Protocol Accepted  
Study Name CraniSeal Registry New Enrollment PAS
Device Name CraniSeal Dural Sealant
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Design:
This is a prospective, multicenter, non-randomized, 2-arm, observational post-approval study designed to evaluate and compare postoperative CSF leakage rates in subjects who receive CraniSeal Dural Sealant and control subjects who receive DuraSeal Dural Sealant as an adjunct to elective infratentorial or supratentorial cranial dural closures. The CraniSeal Dural Sealant arm will consist of subjects who undergo a cranial procedure where CraniSeal hydrogel is administered. The control arm will consist of subjects who undergo a cranial procedure where DuraSeal hydrogel is administered. Sites are not required to enroll in both study arms. Subjects will be followed for 90 days after cranial surgery. Objectives:
The objective of this study is to collect post-approval data comparing the safety and effectiveness of the recently FDA-approved CraniSeal Dural Sealant to DuraSeal Dural Sealant when used by a broad group of physicians under commercial use conditions
Study Population Patients who are scheduled for elective infratentorial or supratentorial cranial surgery that entails a sutured dural incision that needs to be augmented with a dural sealant
Sample Size Number of subjects: 134
Assumptions for sample size estimation: Sample size calculations for the CraniSeal and DuraSeal treatment arms were performed based on the primary effectiveness endpoint, occurrence of CSF leakage or pseudominigocele within 90-days after the cranial surgical procedure. Assuming 95% exact confidence intervals (CI) and true percentages for the primary effectiveness endpoint of 1% for each treatment, a 1:1 ratio of the number of subjects in each arm, and an 80% probability of the CI half-width being less than or equal to 4%, the required sample size per treatment arm is 67 subjects, for a total sample size of 134 subjects.
Number of sites: 20
Sites location: US
Key Study Endpoints Safety Endpoints
Primary: None
Secondary: None
Effectiveness Endpoints
Primary: The primary effectiveness endpoint is the occurrence of cerebrospinal fluid (CSF) leakage within 90-days after the cranial surgical procedure. This endpoint will be summarized by treatment group using frequencies and percentages, together with an exact (Clopper-Pearson) confidence interval (CI) for the true percentage. The observed difference in percentages between treatment groups (DuraSeal Dural Sealant - CraniSeal Dural Sealant), together with a 95% normal approximation CI for the true difference, will also be presented.
Secondary: The secondary endpoint is occurrence of post-operative surgical site infections through 90 days that are judged to be definitely or probably related to the use of the dural sealant. This endpoint will be summarized in the same manner as the primary effectiveness endpoint
Follow-up Visits and Length of Follow-up 90 days


CraniSeal Registry New Enrollment PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/04/2024 01/17/2024 Overdue/Received
1 year report 07/05/2024    
18 month report 01/03/2025    
2 year report 07/05/2025    
3 year report 07/05/2026    
4 year report 07/05/2027    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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