CraniSeal Post Approval Study (NCT06406790) | Clinical Trial Compass
RecruitingPhase 4
CraniSeal Post Approval Study
United States224 participantsStarted 2024-05-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is ≥ 18 years of age
✓. Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia that entails a dural incision
✓. Patient requires a procedure involving surgical wound classification Class I/Clean
✓. Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures.
✓. Patients who are able to comply with study requirements.
Exclusion criteria
✕. Patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/ or any procedure that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded
✕. Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
✕. Patient with diagnosis of severely altered renal (creatinine levels \> 2.0 mg/dL) or hepatic (total bilirubin \> 2.5 mg/dL) function
✕. Patient diagnosed with a compromised immune system or autoimmune disease (WBC count less than 4000/uL or greater than 20,000/uL)
✕. Patients undergoing cranial procedures involving petrous bone drilling
✕. Patients with traumatic injuries to the head or dural disease in planned dural closure area