Scanadu Urine Device Validation Study Protocol

Study Overview
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Brief Summary
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This study will test Scanadu Urine Device for clinical performance and usability.

Detailed Description
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The objectives of this study are to: Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396). Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device. Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels

Official Title
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Scanadu Urine Device Validation Study Protocol

Conditions
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Urinary Tract Infections, Proteinuria, Ketone Urine, Hematuria, Glucose Intolerance

Intervention / Treatment
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* Device: Scanadu Urine Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male 18 years old or older Pregnant or not pregnant Must have experience using an Apple iPhone Have no visual impairments Able to hold Smart Phone horizontally in raised dominant hand Must be able to read and understand English Must provide Informed Consent Exclusion Criteria: Has a known history of a visual impairment that may affect reading and navigating the Scanadu Urine app Unable to void and collect urine specimen for testing Unable to hold phone steady (horizontally) or has history of tremors or conditions such as Parkinson's disease

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usability<br>Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device. | Device: Scanadu Urine Device<br>* Device to allow lay user to perform urinalysis test at home.<br>|
| Active Comparator: Method Comparison<br>Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: The visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396), Scanadu Urine Device tests performed by lab technicians. | Device: Scanadu Urine Device<br>* Device to allow lay user to perform urinalysis test at home.<br>|
| Other: Reproducibility<br>Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels. | Device: Scanadu Urine Device<br>* Device to allow lay user to perform urinalysis test at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire | Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device. | Single visit in one day | 
| Method Comparison: Conduct two tests by following iPhone app (self and patient samples), results in concordance with professional testers; achieve accuracy in different concentrations of six urine analytes each using approximately 20 samples per level. | Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396). | Single visit in one day | 
| Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance. | Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels | Single visit in one day |