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

Mindset Medical1 site in 1 country86 target enrollmentJune 2, 2023

ConditionsVital Sign Evaluation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vital Sign Evaluation
Sponsor: Mindset Medical
Enrollment: 86
Locations: 1
Primary Endpoint: Pulse Rate Accuracy
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

June 2, 2023

End Date

June 29, 2023

Last Updated

6 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mindset Medical

Responsible Party

Sponsor

Eligibility Criteria

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.