Trials / Completed
CompletedNCT02535468
T2Bacteria Panel Pivotal Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,430 (actual)
- Sponsor
- T2 Biosystems · Industry
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".
Conditions
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2016-04-01
- Completion
- 2016-06-01
- First posted
- 2015-08-28
- Last updated
- 2018-08-17
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02535468. Inclusion in this directory is not an endorsement.