A Clinical Data Collection Study of Verily Patch

NCT04727801 | Terminated FDA Device

• 1 other identifier: 102782
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Febrile; Afebrile

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Device: Verily Patch

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.

Device: Verily Patch

Interventions

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).

Afebrile (n=50); Febrile (n=50)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verily Life Sciences LLC: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Marks, MD

  Verily Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: March 11, 2021
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

US (1)