Scanadu Urine Device Validation Study Protocol

Scanadu

Status: Unknown

Conditions: Ketone Urine; Urinary Tract Infections; Hematuria; Proteinuria; Glucose Intolerance

Treatments: Device: Scanadu Urine Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02973178

FO-004

Details and patient eligibility

About

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

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

Usability

Other group

Description:

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.

Treatment:

Device: Scanadu Urine Device

Method Comparison

Active Comparator group

Description:

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.

Treatment:

Device: Scanadu Urine Device

Reproducibility

Other group

Description:

Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels.

Treatment:

Device: Scanadu Urine Device