Repair of Dura MaterNCT07371091
Post-market Clinical Investigation Plan: Collagen Dura Regeneration Membrane - Repair (DMR)
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 Dura Regeneration Membrane - Repair (DMR) 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
- 2 sitesUnited States
- Study dates
- Jul 2026to Dec 2027
- 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: All patients with a dural defect requiring repair with a dural substitute.
Who may be able to join
- Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice
- Patient is 18 years or older
- Patient of child-bearing potential is not pregnant or nursing
- Participant is willing and able to provide consent
Who cannot join
- Patients with a known history of hypersensitivity to bovine derived materials
- Patients that are non-English speaking
- Patients requiring legal representation
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Erica Fox, 617-724-5805, efox15@mgh.harvard.edu
Brian Nahed, MD
Rush University Medical Center
Chicago, Illinois, 60612
Morgan Roll, 312.563.6827, Morgan_L_Roll@rush.edu
Stephan Munich, MD
About this study
Official title: Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase
Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.
Read the detailed description
A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.
- Conditions
- Repair of Dura Mater
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Revision Surgery
Rate of adverse events related to the Subject Device requiring surgical intervention.
Measured: at least one timepoint at 8 months or more post-surgery
Secondary outcomes (4)
Rate of Adverse Events
Intra-operative and post-operative adverse events (i.e., infection, CSF Leak, and Pseudomeningocele)
Measured: at least one timepoint at 8 months or more post-surgery
Product Performance
Score of adequacy of product performance - 1 (poor) to 4 (excellent)
Measured: at least one timepoint at 8 months or more post-surgery
Product Handling at Implantation
Score for product handling at implantation - 1 (poor) to 4 (excellent)
Measured: Initial surgery
Product Adaptability at Implantation
Score for product adaptability at implantation - 1 (poor) to 4 (excellent)
Measured: Initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collagen Matrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371091
- Sponsor's protocol ID
- CIP.088
- Status last verified
- May 2026
- First submitted
- 19 Jan 2026
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase
- ClinicalTrials.gov ID
- NCT07371091
- Acronym / sponsor ID
- CIP.088
- Conditions
- Repair of Dura Mater
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Collagen MatrixIndustry (pharma, biotech, devices)
- Collaborators
- Stryker Nordic
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Jan 2026 (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 Regeneration Membrane - Repair (DMR) in the Post-market Phase.
Detailed description
A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a dural defect requiring repair with a dural substitute.
Key inclusion criteria (4 listed)
- Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice
- Patient is 18 years or older
- Patient of child-bearing potential is not pregnant or nursing
- Participant is willing and able to provide consent
Key exclusion criteria (3 listed)
- Patients with a known history of hypersensitivity to bovine derived materials
- Patients that are non-English speaking
- Patients requiring legal representation
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
Rate of Revision Surgery
Time frame: at least one timepoint at 8 months or more post-surgery
Rate of adverse events related to the Subject Device requiring surgical intervention.
4 secondary outcomes
Rate of Adverse Events
Time frame: at least one timepoint at 8 months or more post-surgery
Product Performance
Time frame: at least one timepoint at 8 months or more post-surgery
Product Handling at Implantation
Time frame: Initial surgery
Product Adaptability at Implantation
Time frame: Initial surgery
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 29 May 2026.
Related trials for Repair of Dura Mater
RecruitingObservational study
Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
Repair of Dura Mater
Not yet recruitingObservational study
Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable
Repair of Dura Mater
RecruitingObservational study
Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)
Repair of Dura Mater
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 May 2026. 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 (347-439-1634, 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: at least one timepoint at 8 months or more post-surgery). 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 29 May 2026.