CraniSeal Post Approval Study

NCT06406790 | Recruiting Phase 4 FDA Device

• 1 other identifier: PRA-CT-0003
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 8

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.

Conditions

Leak, Cerebrospinal Fluid

Outcome Measures

Primary Outcomes (1)

• Absence of CSF Leaks

  absence of CSF leaks on study

  90 days

Other Outcomes (1)

• TEAEs and TESAEs

  90 days

Study Arms (2)

CraniSeal

EXPERIMENTAL

CraniSeal

Device: CraniSeal

DuraSeal

ACTIVE COMPARATOR

DuraSeal

Device: DuraSeal

Interventions

DuraSeal DEVICE

DuraSeal is a PEG Dural Sealant

DuraSeal

CraniSeal DEVICE

CraniSeal is a PEG Dural Sealant

CraniSeal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age
• Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia 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.

You may not qualify if:

• 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 non-autologous duraplasty material that are not collagen based
• Patients requiring re-opening of planned surgical area within 90 days after surgery.
• Patient with a known allergy to FD\&C Blue #1 dye
• 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
• Presence of hydrocephalus
• 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)

Sponsors & Collaborators

• Pramand LLC: lead

Study Sites (8)

Keck Medical Center at USC

Los Angeles, California, 90033, United States

COMPLETED

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Jacobs Institute

Buffalo, New York, 14203, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

M Pace

CONTACT

6172335873; mike.pace@pramandllc.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to dural sealant until they have completed 90 day study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 CraniSeal vs Comparator

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)