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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03965975
Other study ID # S-There Smart Device-2019-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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