NCT02973178

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

November 15, 2016

Last Update Submit

November 21, 2016

Conditions

Urinary Tract InfectionsProteinuriaKetone UrineHematuriaGlucose Intolerance

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

Usability

OTHER

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

Method Comparison

ACTIVE COMPARATOR

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

Reproducibility

OTHER

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

Device: Scanadu Urine Device

Interventions

Scanadu Urine DeviceDEVICE

Device to allow lay user to perform urinalysis test at home.

Method ComparisonReproducibilityUsability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West Coast Research, LLC

Mountain View, California, 94040, United States

RECRUITING

West Coast Research, LLC

San Leandro, California, 94577, United States

COMPLETED

MeSH Terms

Conditions

Urinary Tract InfectionsProteinuriaKetosisHematuriaGlucose Intolerance

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesHemorrhagePathologic ProcessesHyperglycemiaGlucose Metabolism Disorders

Central Study Contacts

Jenny Li

CONTACT

650-567-6389jenny.li@scanadu.com

Daya Ranamukhaarachchi

CONTACT

301-569-1213daya@scanadu.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 25, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 25, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)