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Can a new patch safely protect the brain after surgery?

NCT ID NCT07758790

Disease control Sponsor: DePuy Synthes Products, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This registry study is evaluating the safety and performance of SYNTHECEL, a device used to close and protect the dura—the outer covering of the brain—during cranial surgery. Researchers will follow about 112 participants who undergo craniotomy or craniectomy and receive SYNTHECEL as part of their procedure. The study will track outcomes such as cerebrospinal fluid leakage, adhesion formation, and neurological status to see how well the device works in real-world clinical settings.

What this could mean

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

Active substance
SYNTHECEL, a device used to close and protect the outer covering of the brain during cranial surgery
What this could lead to
If successful, this registry could provide real-world evidence on the safety and performance of SYNTHECEL, potentially supporting its broader use in routine cranial surgeries.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by variations in surgical practice and patient populations.

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

Study facts

What this study's own registry entry says, in plain language.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes participants undergoing cranial dura repair using SYNTHECEL Dura Repair.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant or legally authorized representative who is willing to participate in the registry and provide written informed consent * Participant undergoing SYNTHECEL implantation for cranial dura repair on or after the start date of the registry study Exclusion Criteria: \- Participant with documented or known hypersensitivity or allergic reaction to cellulose or related materials

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As listed by the trial registrant

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

Craniotomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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