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

NCT05853380 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2025-11-03

Study results available
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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).

Conditions

  • Vital Sign Evaluation

Interventions

DEVICE

Informed Vital Core App

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.

Sponsors & Collaborators

  • Mindset Medical

    lead INDUSTRY

Principal Investigators

  • Dan Lubelski, MD · Mindset Medical

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2023-06-29
Completion
2023-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853380 on ClinicalTrials.gov