N/A N=86

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

Vital Sign Evaluation

Bottom Line

View on ClinicalTrials.gov: NCT05853380 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Pulse Rate Accuracy — 67 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Informed Vital Core App (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Mindset Medical
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Pulse Rate Accuracy	67	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05853380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.