Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

ConditionBlood Pressure

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorPerin Health Devices

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 years or older,

Willing and able to provide informed consent,

Able to comply with study procedure.

Disqualifiers

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,

Trial population

The study population will consist of male and female adult participants aged 18 years or older who are willing and able to provide informed consent and comply with the study procedures. Participants may be healthy or have comorbidities, so long as participants are members of any 'Special Population' as defined by the AAMI standards, including but not limited to pregnant individuals, children, and those with an arm circumference greater than 42 cm. Due to the nature of the investigational device, individuals with pacemakers or a history of reactions to medical adhesives may not participate.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Perin Health Patch
Device
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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Cuffless blood pressure measurement performance

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.

Time frame

3 months

Secondary outcomes

Demographic performance variance

Determine any variations in performance on certain demographic groups, including subjects who are overweight, subjects with dark skin pigmentation, or subjects with comorbidities.

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Perin Health Devices

Lead sponsor

Source ClinicalTrials.gov

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