CraniSeal Post Approval Study

Pramand LLC

Status and phase: Enrolling; Phase 4

Conditions: Leak, Cerebrospinal Fluid

Treatments: Device: DuraSeal; Device: CraniSeal

Study type: Interventional

Funder types: Industry

Identifiers

NCT06406790

PRA-CT-0003

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

CraniSeal

Experimental group

Description:

CraniSeal

Treatment:

Device: CraniSeal

DuraSeal

Active Comparator group

Description:

DuraSeal

Treatment:

Device: DuraSeal