Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

August 26, 2024 updated by: Perin Health Devices
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Woodland Hills, California, United States, 91364
        • Recruiting
        • Perin Health Devices
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cuffless blood pressure measurement performance
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic performance variance
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perin Health Devices

Investigators

  • Principal Investigator: Ian M McLane, Ph.D., Perin Health Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

October 15, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHD-001-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Access to the data will be restricted to the study team. If any future or secondary analysis is conducted by other investigators, a formal approval process will be undertaken, including the validation of proper training certificates and data use plans. Training, requests, and approvals will be maintained in Perin Health Devices' electronic quality management system (eQMS). PI McLane will be responsible for the oversight of the electronic and physical data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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