NCT06406790 CraniSeal Post Approval Study

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 224 participants in total. It began in 2024-05-29 with a primary completion date of 2027-02.

Brief 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.

Eligibility Criteria

General Inclusion Criteria: 1. Patient is ≥ 18 years of age 2. Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia that entails a dural incision 3. Patient requires a procedure involving surgical wound classification Class I/Clean 4. Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures. 5. Patients who are able to comply with study requirements. General Exclusion Criteria: 1. 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 2. Patient has had a prior intracranial neurosurgical procedure in the same anatomical location 3. Patient with diagnosis of severely altered renal (creatinine levels \> 2.0 mg/dL) or hepatic (total bilirubin \> 2.5 mg/dL) function 4. Patient diagnosed with a compromised immune system or autoimmune disease (WBC count less than 4000/uL or greater than 20,000/uL) 5. Patients undergoing cranial procedures involving petrous bone drilling 6. Patients with traumatic injuries to the head or dural disease in planned dural closure area 7. Patients who are pregnant or lactating 8. Patient with an active infection 9. Patient is undergoing cranial procedures involving non-autologous duraplasty material that are not collagen based 10. Patients requiring re-opening of planned surgical area within 90 days after surgery. 11. Patient with a known allergy to FD\&C Blue #1 dye 12. Patient is not able to tolerate multiple Valsalva maneuvers, or transient elevation of CSF pressure during Valsalva maneuvers is not possible (e.g. the presence of a temporary or permanent CSF shunt 13. Presence of hydrocephalus 14. Patient with a diagnosis of uncontrolled diabetes (e.g., persistent HbA1c elevation of \>9% despite standard diabetes care), 15. Patient has a documented, uncorrectable clinically significant coagulopathy (e.g., PTT\>37 seconds or INR \>1.5 units) 16. Patient is not likely to comply with the follow-up evaluation schedule. 17. Contraindications to both an MRI and CT scan. 18. Patients participating in any investigational device study within 30 days or currently receiving an investigational drug/biologic therapy. (Observational studies on FDA approved products are not applicable) 19. Patients diagnosed with Meningiomatosis (multiple meningiomas)

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