Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

NCT06574113 | Recruiting FDA Device

• 1 other identifier: PHD-001-24
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Pressure

Keywords

Cuffless blood pressure; Wearable device

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Demographic performance variance

  3 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Perin Health Devices: lead

Study Sites (1)

Perin Health Devices

Woodland Hills, California, 91364, United States

RECRUITING

Study Officials

• Ian M McLane, Ph.D.

  Perin Health Devices

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian M McLane, Ph.D.

CONTACT

8186069389; imclane@phasemargin.com

Valerie Rennoll, Ph.D.

CONTACT

vrennoll@phasemargin.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: August 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: December 31, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

US (1)