Healthy PopulationNCT05534477
Verily Clinical Study Watch Analytical Validation Study
An observational study of Healthy Population and Chronic Disease, run by Verily Life Sciences LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Population, Chronic Disease
- What is being tested?
- Verily Clinical Study Watch, Vivalink ECG Patch and Modus StepWatch 4
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 100 participants will be enrolled. This is a decentralized study across the United States.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Verily Life Sciences
South San Francisco, California, 94080
About this 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.
- Conditions
- Healthy Population, Chronic Disease
- Being tested
- Verily Clinical Study Watch, Vivalink ECG Patch, Modus StepWatch 4
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verily Clinical Study WatchDevice
The Study Watch is an investigational wrist worn wearable device made with biocompatible contact materials containing various sensors capable of continuous recording of physiological, activity, and environmental data.
Vivalink ECG PatchDevice
The Vivalink ECG Patch is a continuously recording ECG monitor and will be used as a reference device for measuring participants' pulse rate, pulse rate variability, and pulse rate coverage. The Vivalink ECG Patch is a medical device manufactured by VivaLNK Inc. and has been cleared by the FDA.
Modus StepWatch 4Device
Modus StepWatch 4 is an ankle-worn wearable medical device, and will be used as a reference device for measuring participants' ambulatory time and daily step count. The Modus StepWatch 4 is FDA listed.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start18 Sep 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verily Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scooter Plowman, MD, Principal investigator, Verily Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534477
- Sponsor's protocol ID
- 104126
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verily Clinical Study Watch Analytical Validation Study
- ClinicalTrials.gov ID
- NCT05534477
- Acronym / sponsor ID
- 104126
- Conditions
- Healthy Population, Chronic Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Verily Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 participants will be enrolled. This is a decentralized study across the United States.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verily Clinical Study WatchThe Study Watch is an investigational wrist worn wearable device made with biocompatible contact materials containing various sensors capable of continuous recording of physiological, activity, and environmental data. | Device | – |
| Vivalink ECG PatchThe Vivalink ECG Patch is a continuously recording ECG monitor and will be used as a reference device for measuring participants' pulse rate, pulse rate variability, and pulse rate coverage. The Vivalink ECG Patch is a medical device manufactured by VivaLNK Inc. and has been cleared by the FDA. | Device | – |
| Modus StepWatch 4Modus StepWatch 4 is an ankle-worn wearable medical device, and will be used as a reference device for measuring participants' ambulatory time and daily step count. The Modus StepWatch 4 is FDA listed. | Device | – |
Primary outcome
Accuracy of pulse rate when wearer is at rest
Time frame: 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.
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).
Sensitivity of movement detection
Time frame: 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.
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.
Specificity of movement detection
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scooter Plowman, MD principal investigator
Verily Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Population and Chronic Disease, run by Verily Life Sciences LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of pulse rate when wearer is at rest (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.