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NCT07774169

Noninvasive Blood Pressure Validation Study

Sponsor: Perin Health Devices

View on ClinicalTrials.gov

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

Interventions

DEVICE

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