A Clinical Data Collection Study of Verily Patch

Febrile Clinical Trial

Official title:

A Clinical Data Collection Study of Verily Patch

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04727801
• Other study ID #: 102782
• Status: Terminated
• Start date: March 11, 2021
• Est. completion date: May 25, 2021

Study information

• Verified date: August 2021
• Source: Verily Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Afebrile
• Febrile
• Fever

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Verily Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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