A Clinical Data Collection Study of Verily Patch

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Data Collection Study of Verily Patch

Conditions
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Febrile, Afebrile

Intervention / Treatment
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* Device: Verily Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Able to read and speak English Able to read and understand the Informed Consent Form Willing to wear Verily Patch in the axillary region Willing to comply with repeated self-measurement of oral and axillary temperatures and willing to record temperature readings Have a working smartphone device and willing to use it for study activities Willing to install study apps on their personal smartphone Willing to comply with all study-related procedures Exclusion Criteria: Pregnant or breastfeeding during study participation Have known allergies to medical grade adhesives Have known cutaneous hypersensitivity Have infection in both axilla Have open injury or rash where the study device will be worn Have a cardiac pacemaker or other implanted electronic medical device(s) Have any additional condition or situation that, in the opinion of the investigator, makes the subject inappropriate for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Febrile (n=50)<br>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. | Device: Verily Patch<br>* 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).<br>|
| Afebrile (n=50)<br>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. | Device: Verily Patch<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |