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

Completed

Conditions studied: Vital Sign Evaluation

In brief

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).

Key facts

Study ID

NCT05853380

Run by

Mindset Medical

People needed

86

Starts

2023-06-02

Expected to finish

2023-06-29

Last updated by the study team

2025-11-03

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Velocity Clinical Research — Mobile, Alabama, United States
• Velocity Clinical Research — La Mesa, California, United States
• Velocity Clinical Research — Meridian, Idaho, United States
• Velocity Clinical Research — Cleveland, Ohio, United States
• Velocity Clinical Research — Columbia, South Carolina, United States
• Velocity Clinical Research — Cedar Park, Texas, United States

Full record on ClinicalTrials.gov

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