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

NCT05853380 | Completed Results FDA Device

• 1 other identifier: IVC-400-006
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 6

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).

Conditions

Vital Sign Evaluation

Outcome Measures

Primary Outcomes (1)

• Pulse Rate Accuracy

  The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate.

  120 seconds

Interventions

Informed Vital Core App DEVICE

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.

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects 22 -85 years of age
• Subjects willing to sign the Informed Consent Form and comply with the protocol

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mindset Medical: lead

Study Sites (6)

Velocity Clinical Research

Mobile, Alabama, 36608, United States

Location

Velocity Clinical Research

La Mesa, California, 91942, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

Velocity Clinical Research

Cleveland, Ohio, 44122, United States

Location

Velocity Clinical Research

Columbia, South Carolina, 29204, United States

Location

Velocity Clinical Research

Cedar Park, Texas, 78613, United States

Location

Results Point of Contact

• Title: Jeremy Markovich
• Organization: Mindset Medical

jeremy@mindsetmedical.com

8583055323

Study Officials

• Dan Lubelski, MD

  Mindset Medical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: June 2, 2023
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)