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NCT04057157 · ClinicalTrials.gov registry record
Post-market Assessment of Biodesign Dural Repair Grafts
A clinical trial, sponsored by Cook Research Incorporated.
- Completed
- Registry status
- 128
- Enrollment target
NCT04057157: Completed study, sponsored by Cook Research Incorporated.
NCT04057157 is a clinical trial that has completed, run by Cook Research Incorporated. The registered enrollment target is 128 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04057157 has completed, sponsored by Cook Research Incorporated.
- COMPLETED
- Registry status
- 128 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- DEVICE Biodesign Dural or Duraplasty Repair Grafts
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2019-09-03 |
| Est. Completion | 2022-09-15 |
What the finished NCT04057157 record still lists
NCT04057157 is an observational study that tracks outcomes without assigning an intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Biodesign Dural or Duraplasty Repair Grafts is the first listed.
NCT04057157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04057157 about?
NCT04057157 is a clinical study titled "Post-market Assessment of Biodesign Dural Repair Grafts". 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.
What is the current status of trial NCT04057157?
This trial is currently completed. The enrollment target is 128 participants. The study started on 2019-09-03. Estimated completion is 2022-09-15.
What interventions are being tested in trial NCT04057157?
The interventions under investigation include: Biodesign Dural or Duraplasty Repair Grafts (DEVICE).
Who is sponsoring clinical trial NCT04057157?
This trial is sponsored by Cook Research Incorporated, which has 24 total clinical trials registered on ClinicalTrials.gov.
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