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| Name | Class |
|---|---|
| The Christie NHS Foundation Trust | OTHER |
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This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entia Liberty | Device | Home monitoring device |
| Measure | Description | Time Frame |
|---|---|---|
| To obtain/validate the value of the total error of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months |
| To obtain/validate the value of the linearity of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months |
| To obtain/validate the value of the bias of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from the outpatients clinic at the Christie, while they are waiting for their blood tests.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christie NHS Foundation Trust | Manchester | United Kingdom | ||||
| Royal Albert Edward Infirmary |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Wigan |
| United Kingdom |