Scanadu Urine Device Validation Study Protocol

Urinary Tract Infections Clinical Trial

Official title:

Scanadu Urine Device Validation Study Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02973178
• Other study ID #: FO-004
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2016
• Last updated: November 21, 2016
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: November 2016
• Source: Scanadu, Inc.
• Contact: Jenny Li
• Phone: 650-567-6389
• Email: jenny.li[@]scanadu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Hematuria
• Ketone Urine
• Proteinuria
• Urinary Tract Infections

Intervention

Device:
• Scanadu Urine Device
Device to allow lay user to perform urinalysis test at home.

Locations

Country	Name	City	State
United States	West Coast Research, LLC	Mountain View	California
United States	West Coast Research, LLC	San Leandro	California

Sponsors (1)

Lead Sponsor	Collaborator
Scanadu, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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