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

Completed

• Conditions: Vital Sign Evaluation

• Registration Number: NCT05853380
• Lead Sponsor: Mindset Medical

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-10
• Status Verified: 2023-06
• Study Start: 2023-06-02
• Primary Completion: 2023-06-29
• Study Completion: 2023-06-29
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse Rate non-inferiority	Baseline only, single visit	The primary endpoint is a non-inferiority comparison to an FDA approved reference device to establish that PR measured with the IVC App are accurate.

Trial Locations

Locations (1)

Velocity Clinical Research; 🇺🇸 Cedar Park, Texas, United States