Actively Recruiting
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase
Led by Collagen Matrix · Updated on 2025-10-15
118
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to monitor the use of the Collagen Dural Regeneration Matrix, known as DuraMatrix-Onlay Plus, in patients requiring repair of the dura mater. It is a prospective, post-market, open-label study conducted at up to 8 sites with 118 participants. The study primarily evaluates the rate of revision surgery needed after using this device and also monitors for adverse events such as cerebrospinal fluid leaks, infections, and pseudomeningocele. Participants will be observed following their initial surgery with follow-up evaluations at least 8 weeks later, which corresponds to the expected resorption time of the device. The study does not include a comparison group and gathers data from usual clinical care without sharing any personal identifying information with the sponsor, Collagen Matrix. During the study, participants will undergo routine clinical assessments to check for the need of revision surgery and any adverse events related to the device. Safety and effectiveness will be monitored through these follow-up visits. The total participation duration varies but includes at least one follow-up evaluation around 8 weeks post-surgery.
CONDITIONS
Brief Title
Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients who require a dura substitute for repair of dura mater
You will not qualify if you...
- Patients with conditions contraindicated according to the device's 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.
Duration - Up to initial hospital discharge
Participants undergo surgery involving the use of the Collagen Dural Regeneration Matrix device and receive immediate care after the procedure.
Duration - At least 8 weeks post surgery
Participants have follow-up evaluations to monitor for adverse events such as CSF leak, infection, and Pseudomeningocele, and to assess the need for revision surgery.
At least 1 follow-up visit approximately 8 weeks after surgery
Trial Site Locations
Total: 2 locations
1
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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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