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Noninvasive Blood Pressure Validation Study
Sponsor: Perin Health Devices
Summary
The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff. Adults 22 to 90 years of age wore the patch while trained observers took blood pressure readings at the same time using a standard arm cuff and stethoscope. The patch readings were then compared to the standard readings to see how closely they match, following recognized international testing standards for blood pressure devices (ISO 81060-2 and IEEE 1708). Participants visited one of three study sites up to three times over about one week. At the final visit, participants also did light resistance band exercise to briefly raise their blood pressure and relaxation activities to lower it, so the patch could be tested while blood pressure was changing.
Key Details
Gender
All
Age Range
22 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
196
Start Date
2026-01-15
Completion Date
2026-06-15
Last Updated
2026-08-19
Healthy Volunteers
Yes
Conditions
Interventions
Chest Worn Blood Pressure Monitor
The Perin Health Patch (PHP) is an investigational, battery powered, wearable physiological monitoring device with an adhesive patch and sensor module, applied to the upper left chest. Cuffless noninvasive blood pressure measurements from the device were compared to a reference sphygmomanometer (dual observer auscultation, same arm simultaneous method).
Locations (1)
Element Boulder
Louisville, Colorado, United States