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

Heart Failure Clinical Trial

— STSD-2019-001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965975
• Other study ID #: S-There Smart Device-2019-001
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: March 2020

Study information

• Verified date: December 2019
• Source: S-There Technologies SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Subject cannot collect urine in receptacle.

• Urinary Catheter

Related Conditions & MeSH terms

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

Intervention

Device:
• Lab Gold Standard
First intervention (assigned to the "All participants" arm).
• S-There
Second intervention (assigned to the "All participants" arm).

Locations

Country	Name	City	State
Spain	Hospital de Cruces	Barakaldo	Bizkaia

Sponsors (3)

Lead Sponsor	Collaborator
S-There Technologies SL	Asociación Instituto de Investigación Sanitaria BioCruces, Hospital de Cruces

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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