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Scanadu Urine Device Validation Study Protocol

Primary Purpose

Urinary Tract Infections, Proteinuria, Ketone Urine

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scanadu Urine Device
Sponsored by
Scanadu, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • West Coast Research, LLCRecruiting
  • West Coast Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Other

Arm Label

Usability

Method Comparison

Reproducibility

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.
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).
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

Secondary Outcome Measures

Full Information

First Posted
November 15, 2016
Last Updated
November 21, 2016
Sponsor
Scanadu, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02973178
Brief Title
Scanadu Urine Device Validation Study Protocol
Official Title
Scanadu Urine Device Validation Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scanadu, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Proteinuria, Ketone Urine, Hematuria, Glucose Intolerance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usability
Arm Type
Other
Arm 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.
Arm Title
Method Comparison
Arm Type
Active Comparator
Arm 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.
Arm Title
Reproducibility
Arm Type
Other
Arm Description
Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels.
Intervention Type
Device
Intervention Name(s)
Scanadu Urine Device
Intervention Description
Device to allow lay user to perform urinalysis test at home.
Primary Outcome Measure Information:
Title
Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire
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.
Time Frame
Single visit in one day
Title
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.
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).
Time Frame
Single visit in one day
Title
Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance.
Description
Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels
Time Frame
Single visit in one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Li
Phone
650-567-6389
Email
jenny.li@scanadu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Daya Ranamukhaarachchi
Phone
301-569-1213
Email
daya@scanadu.com
Facility Information:
Facility Name
West Coast Research, LLC
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Davis
Phone
925-413-1451
First Name & Middle Initial & Last Name & Degree
Jenny Li
Phone
650-567-6389
Facility Name
West Coast Research, LLC
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

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Scanadu Urine Device Validation Study Protocol

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