- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727801
A Clinical Data Collection Study of Verily Patch
August 17, 2021 updated by: Verily Life Sciences LLC
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Data collection to support development activities for Verily Patch
Time Frame: Up to 8 days
|
Data collection to enable device development of the Verily Patch, which includes the development of an algorithm that estimates temperature
|
Up to 8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: William Marks, MD, Verily Life Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2021
Primary Completion (Actual)
May 25, 2021
Study Completion (Actual)
May 25, 2021
Study Registration Dates
First Submitted
January 22, 2021
First Submitted That Met QC Criteria
January 22, 2021
First Posted (Actual)
January 27, 2021
Study Record Updates
Last Update Posted (Actual)
August 20, 2021
Last Update Submitted That Met QC Criteria
August 17, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102782
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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