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New collagen patch for brain lining repair under Real-World watch

NCT ID NCT06802133

Disease control Sponsor: Collagen Matrix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks how well a collagen patch called DuraMatrix-Onlay Plus works when used to repair the dura mater, the tough outer layer covering the brain and spinal cord. Researchers will follow 118 patients who need this patch during surgery to see how many avoid a second operation and whether any side effects occur. The goal is to confirm the patch performs safely and effectively in routine medical practice.

What this could mean

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

Active substance
collagen dural regeneration matrix (DuraMatrix-Onlay Plus)
What this could lead to
If successful, this study will confirm that the patch works well in everyday medical practice, helping surgeons repair the dura mater safely.
What could go wrong
This is an observational study without a comparison group, so it cannot prove the patch is better than other options. Results may not apply to all patients.

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 118 people

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

Started

Jan 2025

Expected to finish

Jul 2026

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 general population will be included in the study where a dura substitute is required for the repair of dura mater

Ages

18 years and older

Sex

Anyone

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: * The general population will be included in the study where a dura substitute is required for the repair of dura mater. Exclusion Criteria: * Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.

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As listed by the trial registrant

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

Repair of dura mater

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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