An interventional study of Scanadu Urine Device in Urinary Tract Infections, Proteinuria and Ketone Urine, sponsored by Scanadu, Inc.. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-25.
Sponsored by Scanadu, Inc. · Not applicable, Interventional, and Diagnostic
This study will test Scanadu Urine Device for clinical performance and usability.
The objectives of this study are to:
779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.
This study's planned enrollment of 300 is above the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →This is the only study on the registry with Scanadu, Inc. as lead sponsor.
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Exclusion Criteria:
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
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
Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels.
Device: Scanadu Urine Device
Device to allow lay user to perform urinalysis test at home.
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.
Time frame: 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).
Time frame: 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
Time frame: Single visit in one day
Plan to share: No
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This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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