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NCT01849458 · ClinicalTrials.gov registry record
BioFiber Scaffold Post-Market Observational Study
A clinical trial, sponsored by Stryker Trauma and Extremities.
- Completed
- Registry status
- 50
- Enrollment target
NCT01849458: Completed study, sponsored by Stryker Trauma and Extremities.
NCT01849458 is a clinical trial that has completed, run by Stryker Trauma and Extremities. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849458 has completed, sponsored by Stryker Trauma and Extremities.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
Primary Outcome
The primary objective is to report the number of participants with device associated adverse events. Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device.
Interventions
- DEVICE BioFiber
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-04 |
What the finished NCT01849458 record still lists
NCT01849458 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which BioFiber is the first listed.
NCT01849458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849458 about?
NCT01849458 is a clinical study titled "BioFiber Scaffold Post-Market Observational Study". The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
What is the current status of trial NCT01849458?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2013-03. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01849458?
The interventions under investigation include: BioFiber (DEVICE).
Who is sponsoring clinical trial NCT01849458?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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