A Clinical Data Collection Study of Verily Patch

Terminated

• Conditions: Afebrile; Febrile
• Interventions: Device: Verily Patch

• Registration Number: NCT04727801
• Lead Sponsor: Verily Life Sciences LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Study Start: 2021-03-11
• Primary Completion: 2021-05-25
• Study Completion: 2021-05-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Febrile (n=50)	Verily Patch	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.
Afebrile (n=50)	Verily Patch	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.

Primary Outcome Measures

Name	Time	Method
Data collection to support development activities for Verily Patch	Up to 8 days	Data collection to enable device development of the Verily Patch, which includes the development of an algorithm that estimates temperature

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States