CraniSeal Post Approval Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Leak, Cerebrospinal Fluid
• Intervention / Treatment: Device: CraniSeal; Device: DuraSeal

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: M Pace; Phone Number: 6172335873; Email: mike.pace@pramandllc.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Completed
      • Keck Medical Center at USC
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Phone Number: 6177325500
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Jacobs institute
      • Contact: Phone Number: 7168884805
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health
      • Contact: Phone Number: 8644557000; Email: crmo@prismahealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CraniSeal	Device: CraniSeal; CraniSeal is a PEG Dural Sealant
Active Comparator: DuraSeal	Device: DuraSeal; DuraSeal is a PEG Dural Sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of CSF Leaks	absence of CSF leaks on study	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAEs and TESAEs	treatment emergent events on study	90 days

Collaborators and Investigators

• Sponsor: Pramand LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebrospinal Fluid Leak
• Other Study ID Numbers: PRA-CT-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No