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Noninvasive Blood Pressure Validation Study

NCT07774169 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 196

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • Blood Pressure Monitoring
  • Blood Pressure

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).

Sponsors & Collaborators

  • Perin Health Devices

    lead INDUSTRY

Eligibility

Min Age
22 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-06-15
Completion
2026-06-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774169 on ClinicalTrials.gov