Verily Clinical Study Watch Analytical Validation Study
Study Details
Study Description
Brief Summary
This study is designed to evaluate the performance of the Verily Clinical Study Watch for the quantification of participants' ambulatory activity and pulse rate in comparison to reference devices.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Accuracy of resting pulse rate during supervised visit [Assessed at the visit at the start of the 2 week wear period]
Accuracy of resting pulse rate measurement will be reported at the start of the 2 week wear period in an overall generally healthy population.
- Accuracy of resting pulse rate during supervised visit [Assessed at the visit at the end of the 2 week wear period]
Accuracy of resting pulse rate measurement will be reported at the end of the 2 week wear period in an overall generally healthy population.
- Accuracy of ambulatory status classification during supervised visit [Assessed at the visit at the start of the 2 week wear period]
Accuracy of ambulatory status classification (ambulatory, non-ambulatory) detection will be reported at the start of the 2 week wear period in an overall generally healthy population.
- Accuracy of ambulatory status classification during supervised visit [Assessed at the visit at the end of the 2 week wear period]
Accuracy of ambulatory status classification (ambulatory, non-ambulatory) detection will be reported at the end of the 2 week wear period in an overall generally healthy population.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant is ≥ 18 and ≤ 80 years old
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Participant understands the study requirements and is able and willing to provide written informed consent
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Participant is without significant limitation in ability to participate in the study, in the opinion of the investigator
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Participant is able to walk without the use of an assistive device (cane, crutch, walker, etc)
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Participant does not have significant cardiovascular medical history (e.g., chronic heart failure or arrhythmias, including atrial fibrillation, bradycardia, tachycardia)
Exclusion Criteria:
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Participant is allergic to nickel or metal jewelry
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Known severe allergy to polyester, nylon, or spandex
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Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
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Participant cannot make arm swings with either arm or is in a situation that prevents arm swings completely with either arm
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Participants who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator
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Participant has a cardiac pacemaker, implantable defibrillator, medical pump, or other implantable medical electronic device
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Participant has a tattoo covering the area where the watch face would rest on either wrist
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Verily Life Sciences | South San Francisco | California | United States | 94080 |
Sponsors and Collaborators
- Verily Life Sciences LLC
Investigators
- Principal Investigator: William Marks, MD, Verily Life Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 104126