A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Device: Velieve U.S.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females 18-80 years of age; Subjects who are healthy or: Subjects with a medical condition that normally present with an abnormal concentration of Leukocytes, Nitrites and Blood: (examples of such conditions include the following): Urinary tract infection (UTI) Patients with suspected or known occult blood in urine Pregnant women Other relevant conditions Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion) Subject is capable and willing to provide informed consent; Subject has facility with both hands; Subject is capable and willing to adhere to the study procedures. Subject is familiar with the use of a smartphone Subject is capable of comprehending and following instructions in English Exclusion Criteria: Subject has dementia. Subject has mental disorders. Subject cannot collect urine in a receptacle. Subject is visually impaired (cannot read the user manual). Any additional reason the study physician believes disqualifies the subject from participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Velieve U.S.<br>Each participant will test their urine sample using the Velieve U.S. device | Device: Velieve U.S.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions. |  | 11 months |