Scanadu Urine Device Validation Study Protocol

• Sponsor: Scanadu, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02973178
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Arms: 3
• Duration (Months): 4
• Patients Per Site: 150
• Patients Per Site Per Month: 37.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections; Proteinuria; Ketone Urine; Hematuria; Glucose Intolerance	Device: Scanadu Urine Device	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Scanadu Urine Device Validation Study Protocol
• Study Start Date: Aug 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Device: Scanadu Urine Device; Device to allow lay user to perform urinalysis test at home.
Active Comparator: 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.	Device: Scanadu Urine Device; Device to allow lay user to perform urinalysis test at home.
Other: Reproducibility 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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).

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Research, LLC	Mountain View	California	United States	94040
2	West Coast Research, LLC	San Leandro	California	United States	94577

Sponsors and Collaborators

• Scanadu, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scanadu, Inc.
• ClinicalTrials.gov Identifier: NCT02973178
• Other Study ID Numbers: FO-004
• First Posted: Nov 25, 2016
• Last Update Posted: Nov 25, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Urinary Tract Infections; Proteinuria; Hematuria; Glucose Intolerance

Study Results

No Results Posted as of Nov 25, 2016