Verily Clinical Study Watch Analytical Validation Study

This study is designed to evaluate the performance of the Verily Clinical Study Watch for the quantification of participants' movement and pulse rate when the wearer is at rest.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Disease; Healthy Population
• Intervention / Treatment: Device: Verily Clinical Study Watch; Device: Vivalink ECG Patch; Device: Modus StepWatch 4

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • South San Francisco, California, United States, 94080
      • Verily Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Up to 100 participants will be enrolled. This is a decentralized study across the United States.

Description

Inclusion Criteria:

• Participant is ≥ 22 and ≤ 80 years old
• Participant understands the study requirements and is able and willing to provide written informed consent
• Participant is without significant limitation in ability to participate in the study, in the opinion of the investigator
• Participant owns a smartphone with a data plan and be the primary user of the smartphone; smartphone must be compatible with the applications used in the study
• Participant is a US Resident

Exclusion Criteria:

• Participant has tremor or significant life-threatening arrhythmia
• Participant is allergic to nickel or metal jewelry
• Participant has a known severe allergy to polyester, nylon, or spandex
• Participant has a known allergic reaction to adhesives or hydrogels
• Participant has a tattoo covering the area where the watch face would rest on either wrist
• Participant has planned international travel during the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of pulse rate when wearer is at rest	To evaluate the accuracy of the Verily Clinical Study Watch's ability to measure pulse rate when wearer is at rest during unsupervised free-living conditions. Pulse rate measurements will be compared against heart rate output from the reference device (FDA cleared ECG patch).	Approximately 14-day at-home observational period with two virtual visits, one at the beginning and the other at the end of the at-home period.
Sensitivity of movement detection	To evaluate the accuracy of the Verily Clinical Study Watch's ability to detect movement (rest vs not rest) during supervised conditions. Movement detection will be compared against virtual supervised observer-reference labels of rest vs not rest.	Approximately 14-day at-home observational period with two virtual visits, one at the beginning and the other at the end of the at-home period.
Specificity of movement detection	To evaluate the accuracy of the Verily Clinical Study Watch's ability to detect movement (rest vs not rest) during supervised conditions. Movement detection will be compared against virtual supervised observer-reference labels of rest vs not rest.	Approximately 14-day at-home observational period with two virtual visits, one at the beginning and the other at the end of the at-home period.

Collaborators and Investigators

• Sponsor: Verily Life Sciences LLC
• Investigators: Principal Investigator: Scooter Plowman, MD, Verily Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 104126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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