Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

Perin Health Devices

Status: Enrolling

Conditions: Blood Pressure

Treatments: Device: Perin Health Patch

Study type: Observational

Funder types: Industry

Identifiers

NCT06574113

PHD-001-24

Details and patient eligibility

About

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).

Full 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 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design