Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06406790

CraniSeal Post Approval Study

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

224

Participants Needed

8

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official 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
  • Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia that involves a dural incision
  • Procedure involves a clean surgical wound (Class I)
  • Patient signs a written informed consent form before any study procedures
  • Patient is able to comply with study requirements
Not Eligible

You will not qualify if you...

  • Procedure involves translabyrinthine, transsphenoidal, transoral approaches or penetration of air sinus or mastoid air cells (except superficial penetration)
  • Prior intracranial neurosurgery in the same location
  • Severe kidney (creatinine > 2.0 mg/dL) or liver (bilirubin > 2.5 mg/dL) dysfunction
  • 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 closure site
  • Pregnancy or lactation
  • Active infection
  • Use of non-collagen based non-autologous duraplasty material
  • Need for re-opening surgical area within 90 days post-surgery
  • Allergy to FD&C Blue #1 dye
  • Inability to tolerate multiple Valsalva maneuvers or presence of CSF shunt
  • Presence of hydrocephalus
  • Uncontrolled diabetes (HbA1c > 9%)
  • Clinically significant coagulopathy (PTT > 37 sec or INR > 1.5)
  • Unlikely to comply with follow-up
  • Contraindications to MRI and CT scans
  • Current participation in investigational device studies or investigational drug/biologic therapy within 30 days
  • Diagnosis of multiple meningiomas (Meningiomatosis)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

M

M Pace

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here