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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Lubelski, MD | Mindset Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research | Mobile | Alabama | 36608 | United States | ||
| Velocity Clinical Research |
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The study recruited subjects from clinics, hospitals, and the general public. The study was conducted in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Open Label, Single Group Assignment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent to Measure
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Open Label, Single Group Assignment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to Capture | Posted | Count of Participants | Participants | 120 seconds |
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120 seconds
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Open Label, Single Group Assignment | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Markovich | Mindset Medical | 8583055323 | jeremy@mindsetmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2023 | Apr 24, 2024 | Prot_SAP_000.pdf |
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| La Mesa |
| California |
| 91942 |
| United States |
| Velocity Clinical Research | Meridian | Idaho | 83642 | United States |
| Velocity Clinical Research | Cleveland | Ohio | 44122 | United States |
| Velocity Clinical Research | Columbia | South Carolina | 29204 | United States |
| Velocity Clinical Research | Cedar Park | Texas | 78613 | United States |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| IVC App Pulse Rate | ECG Heart Rate (beats per minute) | ECG HR is reported for the 69 subjects with comparator data. | Median | Inter-Quartile Range | Beats per Minute |
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| IVC App Report Rate | IVC App successfully reported the Pulse Rate for 69 of 82 subjects | Count of Participants | Participants |
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| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
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