NCT05853380

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Mindset Medical · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-06-02
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2023-05-10
• Last updated: 2025-11-03
• Results posted: 2025-11-03

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study