Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device
STSD-2019-001
(In Spanish, Spain) "Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device"
1 other identifier
interventional
700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
June 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedDecember 5, 2019
December 1, 2019
9 months
May 24, 2019
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
All participants (single arm)
OTHERAll 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).
Interventions
First intervention (assigned to the "All participants" arm).
Second intervention (assigned to the "All participants" arm).
Eligibility Criteria
You may qualify if:
- Patients who came to the emergency room, primary care and nephrology unit.
You may not qualify if:
- Subject cannot collect urine in receptacle.
- Urinary Catheter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- S-There Technologies SLlead
- Biobizkaia Health Research Institutecollaborator
- Hospital de Crucescollaborator
Study Sites (1)
Hospital de Cruces
Barakaldo, Bizkaia, 48903, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2019
First Posted
May 29, 2019
Study Start
June 10, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
December 5, 2019
Record last verified: 2019-12