Urinary Tract InfectionsNCT02973178
Scanadu Urine Device Validation Study Protocol
A study testing Scanadu Urine Device in people with Urinary Tract Infections and Proteinuria, run by Scanadu, Inc. at 2 sites in United States.
Trial summary
This study will test Scanadu Urine Device for clinical performance and usability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections, Proteinuria, Ketone Urine
- What is being tested?
- Scanadu Urine Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
West Coast Research, LLC
Mountain View, California, 94040
Tim Davis, 925-413-1451
Jenny Li, 650-567-6389
- Completed
West Coast Research, LLC
San Leandro, California, 94577
About this study
This study will test Scanadu Urine Device for clinical performance and usability.
Read the 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
- Being tested
- Scanadu Urine Device
- Medical subject headings
- Urinary Tract Infections, Proteinuria, Ketosis, Hematuria, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanadu Urine DeviceDevice
Device to allow lay user to perform urinalysis test at home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Scanadu Urine Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: Single visit in one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scanadu, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973178
- Sponsor's protocol ID
- FO-004
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scanadu Urine Device Validation Study Protocol
- ClinicalTrials.gov ID
- NCT02973178
- Acronym / sponsor ID
- FO-004
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Scanadu, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usability | Other | Device: Scanadu Urine DeviceEvaluate 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 | Active comparator | Device: Scanadu Urine DeviceEvaluate 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. |
| Reproducibility | Other | Device: Scanadu Urine DeviceEvaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female and male
- 18 years old or older
- Pregnant or not pregnant
- Must have experience using an Apple iPhone
- Have no visual impairments
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scanadu Urine DeviceDevice to allow lay user to perform urinalysis test at home. | Device | Method Comparison, Reproducibility, Usability |
Primary outcome
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.
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).
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scanadu Urine Device in people with Urinary Tract Infections and Proteinuria, run by Scanadu, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Li (650-567-6389, jenny.li@scanadu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.