A Clinical Data Collection Study of Verily Patch

NCT ID: NCT04727801

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-11

Study Completion Date

2021-05-25

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.

Detailed Description

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Conditions

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Febrile Afebrile

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Verily Patch

Intervention Type 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).

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.

Verily Patch

Intervention Type 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).

Interventions

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Verily Patch

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).

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Verily Life Sciences LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Marks, MD

Role: STUDY_DIRECTOR

Verily Life Sciences

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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102782

Identifier Type: -

Identifier Source: org_study_id

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