Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Post-market Study.
- Who it may be relevant to
- Registry conditions: Repair of Dura Mater. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Monitoring the Use of Collagen Dura Membrane - Suturable (DMS) in the Post-market Phase
Overview
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.
Interventions
- Other Post-market Study
Prospective case series without a concurrent comparator group.
Primary outcome measures
- Rate of Adverse Events Requiring Surgical Intervention [Time frame: 9 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients with a known history of hypersensitivity to bovine derived materials
- Patients that are non-English speaking
- Subjects requiring Legally Authorized Representative
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Baptist Health South Florida — Miami
Identifiers
NCT: NCT07217132 · CIP.033.2