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

Mindset Medical

Status: Completed

Conditions: Vital Sign Evaluation

Treatments: Device: Informed Vital Core App

Study type: Observational

Funder types: Industry

Identifiers

NCT05853380

IVC-400-006

Details and patient eligibility

About

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).

Enrollment: 86 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design