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

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 Overview

• Status: Completed
• Conditions: Vital Sign Evaluation
• Intervention / Treatment: Device: Informed Vital Core App

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Velocity Clinical Research
  • California
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Velocity Clinical Research
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will recruit subjects from clinics and hospitals and the general public. Enrollment of 85 subjects with an age range of 22-85 years of age with a wide range of skin tone categorization per the Fitzpatrick Scale ranging from 1-6.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Rate non-inferiority	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.	Baseline only, single visit

Collaborators and Investigators

• Sponsor: Mindset Medical
• Investigators: Principal Investigator: Dan Lubelski, MD, Mindset Medical

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IVC-400-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No