Actively Recruiting
Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
Led by Collagen Matrix · Updated on 2025-02-12
110
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of Collagen Dura Substitute Membranes (DuraMatrix and DuraMatrix Onlay) in patients who need repair of a dural defect in the dura mater. It is a multi-center observational clinical series involving 110 patients. The study focuses on monitoring safety outcomes during the post-market phase of these devices, with no personal identifying information disclosed to the sponsor, Collagen Matrix. Patients will be followed prospectively with scheduled assessments over 6 to 9 months, which corresponds to the expected lifetime of the membrane device. The study will primarily assess the occurrence of adverse events that require surgical intervention. Secondary outcomes include monitoring for infections, cerebrospinal fluid leaks, and pseudomeningocele during the same follow-up period. Participants will have regular follow-up visits to evaluate safety outcomes including any complications related to the membrane. Data collection will focus on adverse events and surgical needs. The trial does not involve experimental treatments but observes patients receiving standard care with the collagen dura membrane. The total participation time for each patient is at least 6 to 9 months after membrane implantation.
CONDITIONS
Brief Title
Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a dural defect requiring repair with a dural substitute.
You will not qualify if you...
- Known allergy to bovine collagen products as specified in the device instructions for use.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 9 months
Participants who have undergone dural defect repair with the Collagen Dura Substitute Membrane are observed to monitor for adverse events such as leakage, infection, cerebrospinal fluid leak, and pseudomeningocele.
Follow-up visits at multiple time points during 6 to 9 months
Trial Site Locations
Total: 1 location
1
Medical Collagen of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Meenakshi Paliwal
P
Peggy Hansen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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