Recruiting

Cuffless BP Measurements

Sponsor:

Perin Health Devices

Code:

NCT06574113

Conditions

Blood Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Perin Health Patch

Study Details

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

Study ID

NCT06574113

Start date

Aug 15, 2024

Status verified date

Aug, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Oct 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

85 participants

Anticipated

Interventions and Outcome Measures

Interventions

Perin 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.

Primary outcome measure

  • Cuffless blood pressure measurement performance [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Ian M McLane, Ph.D.

8186069389imclane@phasemargin.com

Valerie Rennoll, Ph.D.

vrennoll@phasemargin.com

Locations

Perin Health Devices

Recruiting

Woodland Hills, California, United States, 91364

Contacts

Ian McLane, Ph.D.

818-606-9389imclane@phasemargin.com

More Information

Sponsor

Perin Health Devices

Last update posted

Aug 28, 2024

Last verified

Aug, 2024

Keywords

  • Cuffless blood pressure
  • Wearable device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Perin Health Devices on 2024-08-28.