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Decision by the Sponsor
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This is a single center, prospective, non-randomized prospective observational data collection study of the Verily Patch. The Verily Patch is an investigational wearable, continuous temperature sensor which will be evaluated against reference oral and axillary temperature measurements to support development activities for the Verily Patch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febrile (n=50) | Febrile is defined as having sublingual temperatures of 37.5 °C or above. All subjects will wear the Verily Patch in the axillary region for up to 8 days. In addition, subjects will measure oral and axillary temperatures using a commercially available thermometer. |
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| Afebrile (n=50) | Afebrile is defined as having sublingual temperatures of less than 37.5 °C. All subjects will wear the Verily Patch in the axillary region for up to 8 days. In addition, subjects will measure oral and axillary temperatures using a commercially available thermometer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verily Patch | Device | The Verily Patch is an investigational wearable temperature sensor that consists of a Patch (Verily Patch), with swappable adhesives, as well as an app (Verily Patch app). |
| Measure | Description | Time Frame |
|---|---|---|
| Data collection to support development activities for Verily Patch | Data collection to enable device development of the Verily Patch, which includes the development of an algorithm that estimates temperature | Up to 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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100 participants (50 febrile and 50 afebrile) will be enrolled at one investigational site. Febrile is defined as having sublingual temperatures of 37.50C or above. Participants that exhibit COVID-19 symptoms and/or COVID-19 diagnosis may be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| William Marks, MD | Verily Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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