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Trial record 1 of 1 for:    NCT05853380
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A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05853380
Recruitment Status : Enrolling by invitation
First Posted : May 10, 2023
Last Update Posted : June 6, 2023
Sponsor:
Information provided by (Responsible Party):
Mindset Medical

Study Description
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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
Vital Sign Evaluation Device: Informed Vital Core App

Study Design
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Study Type : Observational
Estimated 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
Actual Study Start Date : June 2, 2023
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : October 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Pulse Rate non-inferiority [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05853380


Locations
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United States, Alabama
Velocity Clinical Research
Mobile, Alabama, United States, 36608
United States, California
Velocity Clinical Research
La Mesa, California, United States, 91942
United States, Idaho
Velocity Clinical Research
Meridian, Idaho, United States, 83642
United States, Ohio
Velocity Clinical Research
Cincinnati, Ohio, United States, 25242
Velocity Clinical Research
Cleveland, Ohio, United States, 44122
United States, South Carolina
Velocity Clinical Research
Columbia, South Carolina, United States, 29204
United States, Texas
Velocity Clinical Research
Cedar Park, Texas, United States, 78613
Sponsors and Collaborators
Mindset Medical
Investigators
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Principal Investigator: Dan Lubelski, MD Mindset Medical
More Information
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Responsible Party: Mindset Medical
ClinicalTrials.gov Identifier: NCT05853380    
Other Study ID Numbers: IVC-400-006
First Posted: May 10, 2023    Key Record Dates
Last Update Posted: June 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No