Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device (STSD-2019-001)
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|ClinicalTrials.gov Identifier: NCT03965975|
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : December 5, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency, Chronic Heart Failure Diabete Mellitus Diabetes; Nephropathy (Manifestation) Hematuria Urinary Tract Infections||Device: Lab Gold Standard Device: S-There||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||(In Spanish, Spain) "Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device"|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
All participants (single arm)
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).
Device: Lab Gold Standard
First intervention (assigned to the "All participants" arm).
Second intervention (assigned to the "All participants" arm).
- Accuracy to compared device [ Time Frame: Through study completion, an average of 1 month ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965975
|Hospital de Cruces||Recruiting|
|Barakaldo, Bizkaia, Spain, 48903|
|Contact: Nefrología Servicio, Unit 946006000 email@example.com|