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This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entia Liberty | Device | Home Monitoring solution |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%. | At least 24 of the participants are able to complete the Entia Liberty test. | 3 months |
| Number of participants with new severe usability problems identified. | Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves | 3 months |
| Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E) | Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants recruited from the outpatients clinic at the Christie
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buckinghamshire Healthcare NHS Trust | Aylesbury | United Kingdom | ||||
| The Christie NHS Foundation Trust |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Manchester |
| United Kingdom |