Condition: Leak, Cerebrospinal Fluid · Sponsor: Pramand LLC
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.
This description comes directly from the study's public registry record.
M Pace · 6172335873 · mike.pace@pramandllc.com
Always discuss trial participation with your own doctor first.
| Keck Medical Center at USC | Los Angeles, California, United States | Completed |
| Mayo Clinic | Jacksonville, Florida, United States | Recruiting |
| Tampa General Hospital | Tampa, Florida, United States | Recruiting |
| Augusta University | Augusta, Georgia, United States | Recruiting |
| Brigham and Women's Hospital | Boston, Massachusetts, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| Jacobs Institute | Buffalo, New York, United States | Recruiting |
| Prisma Health | Greenville, South Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06406790