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| Name | Class |
|---|---|
| Biobizkaia Health Research Institute | OTHER_GOV |
| Hospital de Cruces | OTHER |
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The objectives of the Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device are:
1.To evaluate the performance of S-There Device in comparison to the golden standard used in the lab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants (single arm) | Other | All study participants once enrolled into the study were asked to collect their midstream urine in the designated urine cups. The urine sample was then sent the Lab and tested sequentially; first by the golden standard techniques used by the Lab (first intervention) and by the S-There device (comparative device - second intervention). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab Gold Standard | Device | First intervention (assigned to the "All participants" arm). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy to compared device | The primary objective of the study is to evaluate the accuracy of the S-There device compared to the Lab gold standards, for each analyte. | Through study completion, an average of 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Cruces | Recruiting | Barakaldo | Bizkaia | 48903 | Spain |
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| S-There | Device | Second intervention (assigned to the "All participants" arm). |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006333 | Heart Failure |
| D003920 | Diabetes Mellitus |
| D007674 | Kidney Diseases |
| D006417 | Hematuria |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014555 | Urination Disorders |
| D006470 | Hemorrhage |
| D007239 | Infections |
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