Scanadu Urine Device Validation Study Protocol

Not Applicable

• Conditions: Urinary Tract Infections; Ketone Urine; Hematuria; Proteinuria; Glucose Intolerance
• Interventions: Device: Scanadu Urine Device

• Registration Number: NCT02973178
• Lead Sponsor: Scanadu, Inc.

Brief Summary

This study will test Scanadu Urine Device for clinical performance and usability.

Detailed Description

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

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-25
• Last Update Posted: 2016-11-25
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usability	Scanadu Urine Device	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.
Reproducibility	Scanadu Urine Device	Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels.
Method Comparison	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.

Primary Outcome Measures

Name	Time	Method
Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire	Single visit in one day	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.
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.	Single visit in one day	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).
Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance.	Single visit in one day	Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels

Trial Locations

Locations (1)

West Coast Research, LLC; 🇺🇸 San Leandro, California, United States