Scanadu Urine Device Validation Study Protocol

November 21, 2016 updated by: Scanadu, Inc.
This study will test Scanadu Urine Device for clinical performance and usability.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Daya Ranamukhaarachchi
  • Phone Number: 301-569-1213
  • Email: daya@scanadu.com

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Recruiting
        • West Coast Research, LLC
        • Contact:
          • Tim Davis
          • Phone Number: 925-413-1451
        • Contact:
          • Jenny Li
          • Phone Number: 650-567-6389
      • San Leandro, California, United States, 94577
        • Completed
        • West Coast Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire
Time Frame: 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.
Single visit in one day
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.
Time Frame: 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).
Single visit in one day
Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance.
Time Frame: Single visit in one day
Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels
Single visit in one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scanadu, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (ESTIMATE)

November 25, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FO-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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