A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
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|ClinicalTrials.gov Identifier: NCT04371159|
Recruitment Status : Suspended (Temporarily suspended due to COVID-19)
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Device: Velieve U.S.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||375 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System|
|Actual Study Start Date :||February 5, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: Velieve U.S.
Each participant will test their urine sample using the Velieve U.S. device
Device: Velieve U.S.
The Velieve U.S. is a home use, in-vitro diagnostic (IVD) device. The device is used for the semi-quantitative detection of blood and leukocytes, and the qualitative detection of nitrites in urine.
- Evaluation of the % agreement of the Velieve U.S., tested by the lay user, as compared to a comparator device, tested by a professional user. [ Time Frame: 11 months ]
- Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions. [ Time Frame: 11 months ]
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): NCT04371159
|United States, Florida|
|Comprehensive Clinical Trials, LLC|
|West Palm Beach, Florida, United States, 33409|