Repair of Dura MaterDM&DMONCT06822920
Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)
An observational study of Repair of Dura Mater, run by Collagen Matrix at 1 site in United States.
Trial summary
Monitoring the Use of Collagen Dura Membrane in the Post-market phase Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Repair of Dura Mater
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 30 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The subject device is intended for all patient populations. The following population is excluded from the study:- * Pregnant Women * Subjects requiring Legally Authorized Representative * Subjects under 18 years of age
Who may be able to join
- Patients with a dural defect requiring repair with a dural substitute.
Who cannot join
- There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical Collagen of Wisconsin
Milwaukee, Wisconsin, 53226
Kaitlin Goetschel
About this study
Official title: Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
Monitoring the Use of Collagen Dura Membrane in the Post-market phase
Read the detailed description
A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.
- Conditions
- Repair of Dura Mater
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the occurrence of adverse event requiring surgical intervention
Measured: 6-9 months
Secondary outcomes (1)
Adverse events i.e., infection, CSF leak and Pseudomeningocele
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start3 Jan 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 110 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
- NCT06822920
- Sponsor's protocol ID
- CIP.010
- Acronym
- DM&DMO
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 12 Feb 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
- ClinicalTrials.gov ID
- NCT06822920
- Acronym / sponsor ID
- DM&DMO / CIP.010
- Conditions
- Repair of Dura Mater
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Collagen MatrixIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Feb 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 Dura Membrane in the Post-market phase
Detailed description
A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject device is intended for all patient populations. The following population is excluded from the study:- * Pregnant Women * Subjects requiring Legally Authorized Representative * Subjects under 18 years of age
Key inclusion criteria (1 listed)
- Patients with a dural defect requiring repair with a dural substitute.
Key exclusion criteria (1 listed)
- There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of the occurrence of adverse event requiring surgical intervention
Time frame: 6-9 months
1 secondary outcome
Adverse events i.e., infection, CSF leak and Pseudomeningocele
Time frame: 6-9 months
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 12 Feb 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.
1 site 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 1 site 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Measurement of the occurrence of adverse event requiring surgical intervention (time frame: 6-9 months). 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 12 Feb 2025.