New sealant tested to keep brain surgery patients Leak-Free

NCT ID NCT06406790

Recruiting now Disease control Sponsor: Pramand LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new sealant called CraniSeal is as safe and effective as the current standard, DuraSeal, at preventing cerebrospinal fluid leaks after elective brain surgery. About 224 adults undergoing cranial surgery will be randomly assigned to receive one of the two sealants. The main goal is to see if CraniSeal is no worse than DuraSeal at preventing leaks, while also monitoring for infections and other side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CraniSeal (a PEG dural sealant device)
What this could lead to: If CraniSeal works as well as DuraSeal, it could offer surgeons another reliable option to prevent spinal fluid leaks after brain surgery.
What could go wrong: This is a phase 4 study comparing two already-approved devices, so no major breakthrough is expected. The main risk is that CraniSeal might not be as effective at preventing leaks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cerebrospinal fluid leak

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LEAK, CEREBROSPINAL FLUID

Contacts and locations

Locations

Augusta University
RECRUITING

Augusta, Georgia, 30912, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Jacobs Institute
RECRUITING

Buffalo, New York, 14203, United States
Keck Medical Center at USC
COMPLETED

Los Angeles, California, 90033, United States
Mayo Clinic
RECRUITING

Jacksonville, Florida, 32224, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Prisma Health
RECRUITING

Greenville, South Carolina, 29605, United States
Tampa General Hospital
RECRUITING

Tampa, Florida, 33606, United States