Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06406790

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

Led by Pramand LLC · Updated on 2026-02-20

224

Participants Needed

8

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two dural sealant devices, CraniSeal and DuraSeal, used during elective cranial surgeries. This post-approval study aims to determine whether CraniSeal is no worse than DuraSeal in preventing cerebrospinal fluid (CSF) leaks after surgery. The study also collects data on safety outcomes such as surgical site infections and adverse events related to the devices. Participants will be randomly assigned to receive either the CraniSeal or DuraSeal dural sealant as an addition to traditional sutured dural closure during their cranial surgery. Both devices are PEG-based dural sealants. The study is single-blinded and focuses on procedures involving either infratentorial or supratentorial cranial surgery with a clean surgical wound classification. During the study, participants will be monitored for 90 days after surgery to assess the absence of CSF leaks, the primary outcome measure. Researchers will also track additional safety outcomes and adverse events. Participants must comply with follow-up visits and evaluations as part of the study process. The total duration includes the postoperative period up to 90 days for safety and effectiveness assessments.

CONDITIONS

Brief Title

CraniSeal Post Approval Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years of age or older
  • Scheduled for elective infratentorial or supratentorial cranial surgery under general anesthesia involving a dural incision
  • Surgical wound classification is Class I/Clean
  • Signed informed consent form before study procedures
  • Able to comply with study requirements
Not Eligible

You will not qualify if you...

  • Requires cranial procedures involving translabyrinthine, transsphenoidal, transoral approaches or penetration of air sinus or mastoid air cells (except superficial penetration)
  • Prior intracranial neurosurgery in the same anatomical location
  • Severely altered renal function (creatinine > 2.0 mg/dL) or hepatic function (total bilirubin > 2.5 mg/dL)
  • Compromised immune system or autoimmune disease (WBC count < 4000/uL or > 20,000/uL)
  • Cranial procedures involving petrous bone drilling
  • Traumatic head injuries or dural disease at planned dural closure area
  • Pregnant or lactating
  • Active infection
  • Use of non-collagen based non-autologous duraplasty material
  • Re-opening of surgical area within 90 days after surgery
  • Known allergy to FD&C Blue #1 dye
  • Unable to tolerate multiple Valsalva maneuvers or transient CSF pressure elevation (e.g., presence of CSF shunt)
  • Presence of hydrocephalus
  • Uncontrolled diabetes with persistent HbA1c > 9%
  • Documented significant coagulopathy (PTT > 37 seconds or INR > 1.5)
  • Unlikely to comply with follow-up schedule
  • Contraindications to MRI and CT scans
  • Participation in any investigational device study within 30 days or current investigational drug/biologic therapy
  • Diagnosis of meningiomatosis (multiple meningiomas)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants undergo elective cranial surgery where either CraniSeal or DuraSeal dural sealant is applied during the procedure.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 90 days

Participants are monitored after surgery to assess safety and effectiveness of the dural sealant, including checking for cerebrospinal fluid leaks.

Approximately 3 follow-up visits (in-person)

Trial Site Locations

Total: 8 locations

1

Keck Medical Center at USC

Los Angeles, California, United States, 90033

Completed

2

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

3

Tampa General Hospital

Tampa, Florida, United States, 33606

Actively Recruiting

4

Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

5

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

6

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

7

Jacobs Institute

Buffalo, New York, United States, 14203

Actively Recruiting

8

Prisma Health

Greenville, South Carolina, United States, 29605

Actively Recruiting

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Research Team

M

M Pace

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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