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This study will test Scanadu Urine Device for clinical performance and usability.
The objectives of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Method Comparison | Active Comparator | Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to:
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| Reproducibility | Other | Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scanadu Urine Device | Device | Device to allow lay user to perform urinalysis test at home. |
|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Li | Contact | 650-567-6389 | jenny.li@scanadu.com | |
| Daya Ranamukhaarachchi | Contact | 301-569-1213 | daya@scanadu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Research, LLC | Recruiting | Mountain View | California | 94040 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 17, 2017 | |
| Unrelease | Yes | |
| Release | Jan 30, 2017 | |
| Reset | Mar 20, 2017 | |
| Release | Jul 27, 2018 | |
| Reset | Jan 24, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 17, 2017 | Yes | |||
| Jan 30, 2017 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D011507 | Proteinuria |
| D007662 | Ketosis |
| D006417 | Hematuria |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| West Coast Research, LLC | Completed | San Leandro | California | 94577 | United States |
| Mar 20, 2017 |
| Jul 27, 2018 | Jan 24, 2019 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |