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Clinical Trial Summary

The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance,including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the Velieve U.S. device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device.

The use of the Velieve U.S. device will be evaluated for identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04371159
Study type Interventional
Source Healthy.io Ltd.
Contact
Status Completed
Phase N/A
Start date February 5, 2020
Completion date May 30, 2020

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