NCT06802133 · Collagen Matrix
Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
What this study is about
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
View original scientific description
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Interventions
OTHER
Post Market Study
Prospective case series without a concurrent comparator group.
Primary outcome measures
Rate of Revision Surgery
Time frame: 8 weeks
Adequate healing of dural defects without need for a revision surgery or second intervention
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The general population will be included in the study where a dura substitute is required for the repair of dura mater.
Exclusion criteria
- Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Where
- Augusta, Georgia
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2025 · Source of record for eligibility and locations