Clinical Trials

Inclusion Criteria:

* Patient is ≥ 18 years of age.
* Patient is scheduled for an elective infratentorial or supratentorial cranial procedure 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:
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* 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.
* Patients who are pregnant or lactating.
* Patient with an active infection.
* Patient is undergoing cranial procedures involving synthetic or non-autologous duraplasty material that are not collagen based.
* Patient with a known allergy to FD\&C Blue #1 dye.
* Patient is not able to tolerate multiple Valsalva maneuvers, or an intraoperative CSF shunt does not allow for transient elevation of CSF pressure during Valsalva maneuvers.
* Patient with a diagnosis of uncontrolled diabetes (e.g., persistent HbA1c elevation of \>9% despite standard diabetes care),
* Patient has a documented, uncorrectable clinically significant coagulopathy (e.g., PTT\>37 seconds or INR \>1.5 units)
* Patient is not likely to comply with the follow-up evaluation schedule.
* Contraindications to both an MRI and CT scan.
* Patients participating in any investigational device study within 30 days or currently receiving an investigational drug/biologic therapy.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/13/2024. Questions regarding updates should be directed to the study team contact.