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

Sponsor
Mindset Medical (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05853380
Collaborator
(none)
85
Enrollment
7
Locations
5.1
Anticipated Duration (Months)
12.1
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Informed Vital Core App

Study Design

Study Type:
Observational
Anticipated Enrollment :
85 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Anticipated Study Start Date :
May 12, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Oct 15, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Velocity Clinical Research Mobile Alabama United States 36608
2 Velocity Clinical Research La Mesa California United States 91942
3 Velocity Clinical Research Meridian Idaho United States 83642
4 Velocity Clinical Research Cincinnati Ohio United States 25242
5 Velocity Clinical Research Cleveland Ohio United States 44122
6 Velocity Clinical Research Columbia South Carolina United States 29204
7 Velocity Clinical Research Cedar Park Texas United States 78613

Sponsors and Collaborators

  • Mindset Medical

Investigators

  • Principal Investigator: Dan Lubelski, MD, Mindset Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mindset Medical
ClinicalTrials.gov Identifier:
NCT05853380
Other Study ID Numbers:
  • IVC-400-006
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of May 10, 2023