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Clinical Trials/NCT03965975
NCT03965975
Unknown
N/A

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

S-There Technologies SL1 site in 1 country700 target enrollmentJune 10, 2019
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ConditionsRenal Insufficiency, ChronicHeart FailureDiabete MellitusDiabetes; Nephropathy (Manifestation)HematuriaUrinary Tract Infections

Overview

Phase
N/A
Intervention
Not specified
Conditions
Renal Insufficiency, Chronic
Sponsor
S-There Technologies SL
Enrollment
700
Locations
1
Primary Endpoint
Accuracy to compared device
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2019
End Date
March 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
S-There Technologies SL
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •Subject cannot collect urine in receptacle.
  • •Urinary Catheter

Outcomes

Primary Outcomes

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.

Study Sites (1)

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