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Recruitment Paused for data review
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This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system. At the same time, remnant routine blood samples used for Complete Blood Count (CBC) testing from the same participants will be tested on the investigation system. The participants' CBC results analyzed on the gold standard laboratory analyzer (comparator) will be collected and compared against the results obtained from the testing of capillary blood samples and remnant blood samples on the investigational system. The participants' involvement in the study is only for the duration of collecting the blood samples. No follow-up is anticipated. The results from the investigational system is for research use only and will not inform or change the participants' treatment or care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | All participants to undergo the same study method. Where all participants are to donate capillary blood to complete 2 tests on the investigational system and the remnant blood sample from routine CBC testing will also be tested on the investigational system. The routine CBC results will be compared to the results obtained by the investigational system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entia Liberty System | Device | See arm/group description |
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| Measure | Description | Time Frame |
|---|---|---|
| To validate the measurement performance of the investigational system (bias and %bias) | The difference between the measured parameters of the comparator and investigational system will provide the bias (and therefore also the % bias) of the investigational system, which will be checked against pre-determined acceptance criteria. | through study completion, estimated 6 months |
| To validate the measurement performance of the investigational system (regression) | The plotted difference between the measured parameters of the comparator and investigational system will provide the regression, which will be checked against pre-determined acceptance criteria. | through study completion, estimated 6 months |
| To validate the measurement performance of the investigational system (CV and SD) | The difference between the measured parameters of the comparator and investigational system will inform the Coefficient of Variation and Standard Deviation of the dataset, which will be checked against pre-determined acceptance criteria. | through study completion, estimated 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Cancer patients undergoing treatment and attending clinic for Complete Blood Count (CBC) test
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White - Temple | Temple | Texas | 76508 | United States | ||
| Queen Margaret Hospital |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Dunfermline |
| Fife |
| KY12 0SU |
| United Kingdom |
| North Wales Clinical Research Facility | Wrexham | Wrexham County Borough | LL13 7YP | United Kingdom |