"Collection of Samples for the Development and Validation of the Unyvero Invasive Joint Infection (IJI) Application"
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- STATUS
- Not Recruiting
Summary
This sample collection study will be a multi-center competitive enrollment, non-interventional study conducted at three or more institutions in the United States and/or around the world. The study will use residual synovial fluid samples takes from subjects suspected with invasive joint infections (IJI). This will include samples collected from the native or prosthetic joints. The study will collect synovial fluid samples that are confirmed positive for one or more IJI panel microorganisms as well as a defined number of samples negative for infection. These samples would otherwise be discarded after clinical testing for patient care.
Samples will be collected, de-identified and frozen at the clinical sites and batch shipped to the Sponsor for testing. Additionally, samples will be tested at IU under a different protocol in the future.
Description
This sample collection study will be a multi-center competitive enrollment, non-interventional study conducted at three or more institutions in the United States and/or around the world. The study will use residual synovial fluid samples takes from subjects suspected with invasive joint infections (IJI). This will include samples collected from the native or prosthetic joints. The study will collect synovial fluid samples that are confirmed positive for one or more IJI panel microorganisms as well as a defined number of samples negative for infection. These samples would otherwise be discarded after clinical testing for patient care.
Samples will be collected, de-identified and frozen at the clinical sites and batch shipped to the Sponsor for testing. Additionally, samples will be tested at IU under a different protocol in the future.
Details
| Condition | Unyvero Invasive Joint Infection |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX8520 |
| Last Modified on | 19 February 2024 |
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