Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device
NCT ID: NCT03965975
Last Updated: 2019-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
700 participants
INTERVENTIONAL
2019-06-10
2020-03-31
Brief Summary
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1.To evaluate the performance of S-There Device in comparison to the golden standard used in the lab.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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All participants (single arm)
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).
Lab Gold Standard
First intervention (assigned to the "All participants" arm).
S-There
Second intervention (assigned to the "All participants" arm).
Interventions
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Lab Gold Standard
First intervention (assigned to the "All participants" arm).
S-There
Second intervention (assigned to the "All participants" arm).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Urinary Catheter
18 Years
ALL
Yes
Sponsors
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Biocruces Bizkaia Health Research Institute
OTHER_GOV
Hospital de Cruces
OTHER
S-There Technologies SL
INDUSTRY
Responsible Party
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Locations
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Hospital de Cruces
Barakaldo, Bizkaia, Spain
Countries
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Facility Contacts
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Other Identifiers
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S-There Smart Device-2019-001
Identifier Type: -
Identifier Source: org_study_id
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