Trials / Completed
CompletedNCT05025124
Entia Liberty: Accuracy and Precision
Entia Liberty: Analytical Performance Validation - Accuracy and Precision
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 530 (actual)
- Sponsor
- Entia Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Excess blood flagged by the laboratory meeting our requirements will be tested on the Entia Liberty device and have its results compared against the laboratory results. Samples will also be flagged for precision testing (same blood sample, split into 10 Entia Liberty samples).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Entia Liberty | Home monitoring system |
Timeline
- Start date
- 2022-10-03
- Primary completion
- 2022-12-14
- Completion
- 2022-12-14
- First posted
- 2021-08-27
- Last updated
- 2023-01-27
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05025124. Inclusion in this directory is not an endorsement.