A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients

Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).

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Key information

Conditions

Vital Sign Evaluation

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Velocity Clinical Research, Mobile, Alabama, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects 22 -85 years of age
Subjects willing to sign the Informed Consent Form and comply with the protocol

Exclusion criteria

Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin
Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement
Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject
Condition that does not allow the subject to remain still for 60 seconds at a time
Subjects with cardiac arrhythmia
Any known medical condition which may result in an inaccurate measurement using the reference device
Subjects with the inability to complete an ECG.

Treatment and study plan

Informed Vital Core App

Device

All subjects assigned to a single arm, pulse rate measurement will be collected, calculated, and displayed on the web based application. A conventional ECG device will also be used to collect and display the heart rate at the same time. If additional consent is obtained subjects may provide blood pressure and SpO2 measurements for the web based application.

Primary outcomes

Pulse Rate Accuracy

Time frame: 120 seconds

The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate.

Sponsors and collaborators

Lead sponsor

Mindset Medical

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: May 10, 2023
Registry last updated: Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed