CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
Informed Vital Core Appdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05853380
NCT05853380N/ACompleted
CompareCT.gov

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

Mindset Medical·observational·Posted May 10, 2023·Updated Nov 3, 2025

In Brief

An observational study evaluating Informed Vital Core App for Vital Sign Evaluation. Completed, enrolled 86 participants across 6 sites.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsVital Sign Evaluation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMay 10, 2023
Enrollment StartJun 2, 2023
Primary CompletionJun 29, 2023
TodayJul 2, 2026
Enrollment to primary: 27 daysPosted 3.1 years ago

Interventions

Informed Vital Core Appdevice

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.