Status:

RECRUITING

Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

Lead Sponsor:

Perin Health Devices

Conditions:

Blood Pressure

Eligibility:

All Genders

18+ years

Brief Summary

This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).

Detailed Description

The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional...

Eligibility Criteria

Inclusion

  • Adults aged 18 years or older,
  • Willing and able to provide informed consent,
  • Able to comply with study procedure.

Exclusion

  • Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference \> 42 cm),
  • Patient with a pacemaker,
  • History of reactions to medical adhesives,
  • Inability to comply with the study procedure,
  • Non-English Speaker.

Key Trial Info

Start Date :

August 15 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

85 Patients enrolled

Trial Details

Trial ID

NCT06574113

Start Date

August 15 2024

End Date

December 31 2024

Last Update

August 28 2024

Active Locations (1)

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Perin Health Devices

Woodland Hills, California, United States, 91364