Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2016-08-31
2016-12-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Usability
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.
Scanadu Urine Device
Device to allow lay user to perform urinalysis test at home.
Method Comparison
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.
Scanadu Urine Device
Device to allow lay user to perform urinalysis test at home.
Reproducibility
Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels.
Scanadu Urine Device
Device to allow lay user to perform urinalysis test at home.
Interventions
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Scanadu Urine Device
Device to allow lay user to perform urinalysis test at home.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Scanadu, Inc.
INDUSTRY
Responsible Party
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Locations
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West Coast Research, LLC
Mountain View, California, United States
West Coast Research, LLC
San Leandro, California, United States
Countries
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Central Contacts
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Facility Contacts
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Tim Davis
Role: primary
Jenny Li
Role: backup
Other Identifiers
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FO-004
Identifier Type: -
Identifier Source: org_study_id