An observational study in Cerebrospinal Fluid Leak, sponsored by Cook Research Incorporated. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-14.
Sponsored by Cook Research Incorporated · Observational
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
45 studies on the registry are indexed under Cerebrospinal Fluid Leak; 10 are open to participants now.
This study's enrollment of 128 is above the median of 96 across 14 observational studies indexed under Cerebrospinal Fluid Leak.
Browse Cerebrospinal Fluid Leak studies →Cook Research Incorporated is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who have had dura mater repair using a Biodesign Dural or Duraplasty Graft.
Exclusion Criteria:
Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use.
Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage
Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis).
Time frame: 2 months
Plan to share: Undecided — Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Cook Research Incorporated