NCT05853380|CompletedResultsFDA Device
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Sponsor study identifier
observational
86
1 country
6
Study Start
June 2, 2023
Actual (reported)Primary Completion
June 29, 2023
Actual (reported)Study Completion
June 29, 2023
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 29, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2023
Actual (reported)May 10, 2023
Actual (reported)June 2, 2023
Actual (reported)June 29, 2023
Actual (reported)June 29, 2023
Actual (reported)November 3, 2025
Actual (reported)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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Velocity Clinical Research
Mobile, Alabama, 36608, United States
Velocity Clinical Research
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
Dan Lubelski, MD
Mindset Medical
86 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2023
First Posted
May 10, 2023
Study Start
June 2, 2023
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 29, 2023
Actual (reported)Study Completion
June 29, 2023
Actual (reported)Last Updated
November 3, 2025
Results First Posted
November 3, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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