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

(In Spanish, Spain) Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03965975

Acronym

STSD-2019-001

Enrollment

700

Registered

2019-05-29

Start date

2019-06-10

Completion date

2020-03-31

Last updated

2019-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Mellitus, Diabetes; Nephropathy (Manifestation), Heart Failure, Hematuria, Renal Insufficiency, Chronic, Urinary Tract Infections

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.

Interventions

DEVICELab Gold Standard

First intervention (assigned to the All participants arm).

DEVICES-There

Second intervention (assigned to the All participants arm).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Subject cannot collect urine in receptacle. * Urinary Catheter

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026