Repair of Dura MaterNCT07217132
Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable
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 - Suturable (DMS) 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
- What is being tested?
- Post-market Study
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Sep 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
- 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
- Patients with a dural defect requiring repair with a dural substitute
- Patient is 18 years or older
- Patient of child-bearing potential is not pregnant or nursing
Who cannot join
- Patients with a known history of hypersensitivity to bovine derived materials
- Patients that are non-English speaking
- Subjects requiring Legally Authorized Representative
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
Baptist Health South Florida
Miami, Florida, 33176
Starlie Belnap, PhD, 7865961825, starlieb@baptisthealth.net
Michael W McDermott, MD
About this study
Official title: Monitoring the Use of Collagen Dura Membrane - Suturable (DMS) in the Post-market Phase
Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase
Read the detailed description
A prospective, post-market clinical study at a maximum of three sites, with an enrollment of 54 subjects. The primary endpoint of the study will be the rate of adverse events related to the Subject Device requiring surgical intervention. The date of each event will be recorded and assessed, including at least one timepoint of 9 months of more post-operatively. Secondary endpoints will include all adverse events (i.e., infection, CSF Leak, and Pseudomeningocele), score of adequacy of product performance, score for product handling at implantation, and score for product adaptability at implantation.
No original patient records or patient 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 Adverse Events Requiring Surgical Intervention
Rate of adverse events related to subject device and requiring surgical intervention.
Measured: 9 months
Secondary outcomes (4)
Rate of Adverse Events
Rate of all product related adverse events or complications.
Measured: 9 months
Score of adequacy of product performance
rated yes/no by clinician
Measured: 9 months
Score for Product Handling at Implantation
Rated on a scale from 1 (poor) to 4 (excellent) by clinician.
Measured: 9 months
Score for Product Adaptability at Implantation
Rate on a scale of 1 (poor) to 4 (excellent) by clinician.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collagen Matrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baptist Health South Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217132
- Sponsor's protocol ID
- CIP.033.2
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 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 Dura Membrane - Suturable (DMS) in the Post-market Phase
- ClinicalTrials.gov ID
- NCT07217132
- Acronym / sponsor ID
- CIP.033.2
- Conditions
- Repair of Dura Mater
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Collagen MatrixIndustry (pharma, biotech, devices)
- Collaborators
- Baptist Health South Florida
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Oct 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 - Suturable (DMS) in the post-market phase
Detailed description
A prospective, post-market clinical study at a maximum of three sites, with an enrollment of 54 subjects. The primary endpoint of the study will be the rate of adverse events related to the Subject Device requiring surgical intervention. The date of each event will be recorded and assessed, including at least one timepoint of 9 months of more post-operatively. Secondary endpoints will include all adverse events (i.e., infection, CSF Leak, and Pseudomeningocele), score of adequacy of product performance, score for product handling at implantation, and score for product adaptability at implantation.
No original patient records or patient 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 (3 listed)
- Patients with a dural defect requiring repair with a dural substitute
- Patient is 18 years or older
- Patient of child-bearing potential is not pregnant or nursing
Key exclusion criteria (3 listed)
- Patients with a known history of hypersensitivity to bovine derived materials
- Patients that are non-English speaking
- Subjects requiring Legally Authorized Representative
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 Adverse Events Requiring Surgical Intervention
Time frame: 9 months
Rate of adverse events related to subject device and requiring surgical intervention.
4 secondary outcomes
Rate of Adverse Events
Time frame: 9 months
Score of adequacy of product performance
Time frame: 9 months
Score for Product Handling at Implantation
Time frame: 9 months
Score for Product Adaptability at Implantation
Time frame: 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 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.
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 3 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 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 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?
Rate of Adverse Events Requiring Surgical Intervention (time frame: 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 15 Oct 2025.