Repair of Dura MaterNCT06802133
Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
An observational study of Repair of Dura Mater, run by Collagen Matrix at 2 sites in United States.
Trial summary
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Repair of Dura Mater
- What is being tested?
- Post Market Study
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2025to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The general population will be included in the study where a dura substitute is required for the repair of dura mater
Who may be able to join
- The general population will be included in the study where a dura substitute is required for the repair of dura mater.
Who cannot join
- Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
Candelario Laserna, MD, CALASERNA@augusta.edu
Natasha Flores, NFLORES@augusta.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Sophie A Munn, samunn@mgh.harvard.edu
Erica Fox, efox15@mgh.harvard.edu
About this study
Official title: Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Read the detailed description
A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician.
No original patient records or personal identifying information will be disclosed to Collagen Matrix.
- Conditions
- Repair of Dura Mater
- Being tested
- Post Market Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Market StudyOther
Prospective case series without a concurrent comparator group.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Revision Surgery
Adequate healing of dural defects without need for a revision surgery or second intervention
Measured: 8 weeks
Secondary outcomes (1)
Rate of Adverse events
Rate of product-related adverse events or complications
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start13 Jan 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repair of Dura MaterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collagen Matrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802133
- Sponsor's protocol ID
- CIP.057_DMOP
- Status last verified
- Oct 2025
- First submitted
- 27 Jan 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
- ClinicalTrials.gov ID
- NCT06802133
- Acronym / sponsor ID
- CIP.057_DMOP
- Conditions
- Repair of Dura Mater
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Collagen MatrixIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Detailed description
A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician.
No original patient records or personal identifying information will be disclosed to Collagen Matrix.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The general population will be included in the study where a dura substitute is required for the repair of dura mater
Key inclusion criteria (1 listed)
- The general population will be included in the study where a dura substitute is required for the repair of dura mater.
Key exclusion criteria (1 listed)
- Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post Market StudyProspective case series without a concurrent comparator group. | Other | – |
Primary outcome
Rate of Revision Surgery
Time frame: 8 weeks
Adequate healing of dural defects without need for a revision surgery or second intervention
1 secondary outcome
Rate of Adverse events
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Repair of Dura Mater, run by Collagen Matrix at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meenakshi Paliwal (2014051477 ext. 324, mpaliwal@regenity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Revision Surgery (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.