Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device

Not Applicable

• Conditions: Urinary Tract Infections; Diabetes; Nephropathy (Manifestation); Heart Failure; Hematuria; Renal Insufficiency, Chronic; Diabete Mellitus
• Interventions: Device: Lab Gold Standard; Device: S-There

• Registration Number: NCT03965975
• Lead Sponsor: S-There Technologies SL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Study Start: 2019-06-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-05
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Patients who came to the emergency room, primary care and nephrology unit.

Exclusion Criteria

• Subject cannot collect urine in receptacle.
• Urinary Catheter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants (single arm)	Lab Gold Standard	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).
All participants (single arm)	S-There	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).

Primary Outcome Measures

Name	Time	Method
Accuracy to compared device	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.

Trial Locations

Locations (1)

Hospital de Cruces; 🇪🇸 Barakaldo, Bizkaia, Spain