Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06574113

Enrollment

Registered

2024-08-27

Start date

2024-08-15

Completion date

2024-12-31

Last updated

2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

Cuffless blood pressure, Wearable device

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

Interventions

DEVICEPerin Health Patch

The Perin Health Patch (PHP)is a multimodal wearable health patch, which combines auscultation, electrocardiography (ECG), pulse oximetry via photoplethysmography (PPG), bioimpedance (BioZ), skin temperature, and motion and tilt sensors. The PHP integrates multiwavelength PPG (MWPPG) with blue, green, red, and IR LEDs, allowing for precise calculation of PTT, PWV, and related unique parameters, that are used for the calculation of cuffless blood pressure.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Cuffless blood pressure measurement performance	3 months	Calculate the mean error and standard deviation of blood pressure (BP) measurements from the PHP relative to the ambulatory blood pressure cuff and determine compliance of the PHP's performance with AAMI standards and ISO 81060-2.

Secondary

Measure	Time frame	Description
Demographic performance variance	3 months	Determine any variations in performance on certain demographic groups, including subjects who are overweight, subjects with dark skin pigmentation, or subjects with comorbidities.

Countries

United States

Contacts

Primary ContactIan M McLane, Ph.D.

imclane@phasemargin.com8186069389

Backup ContactValerie Rennoll, Ph.D.

vrennoll@phasemargin.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026