CraniSeal Post Approval Study
Recruiting now · Phase 4
Conditions studied: Leak, Cerebrospinal Fluid
In brief
To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.
Key facts
- Study ID
- NCT06406790
- Run by
- Pramand LLC
- People needed
- 224
- Starts
- 2024-05-29
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Prisma Health — Greenville, South Carolina, United States (enrolling)
- Mayo Clinic — Jacksonville, Florida, United States (enrolling)
- Tampa General Hospital — Tampa, Florida, United States (enrolling)
- Augusta University — Augusta, Georgia, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Jacobs Institute — Buffalo, New York, United States (enrolling)
- Keck Medical Center at USC — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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