CraniSeal Post Approval Study

Description

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.

Conditions

Leak, Cerebrospinal Fluid

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Study Overview

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Study Details

Study overview

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.

A Multicenter, Single-Blind, Prospective Randomized Post-Approval Study Comparing the Safety and Effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant for Dural Sealing in Elective Cranial Surgery

CraniSeal Post Approval Study

Condition
Leak, Cerebrospinal Fluid
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Buffalo

Jacobs Institute, Buffalo, New York, United States, 14203

Greenville

Prisma Health, Greenville, South Carolina, United States, 29605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pramand LLC,

Study Record Dates

2026-02