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Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device (STSD-2019-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965975
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborators:
Asociación Instituto de Investigación Sanitaria BioCruces
Hospital de Cruces
Information provided by (Responsible Party):
S-There Technologies SL

Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
±25% 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device
Official Title  ICMJE (In Spanish, Spain) "Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device"
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Renal Insufficiency, Chronic
  • Heart Failure
  • Diabete Mellitus
  • Diabetes; Nephropathy (Manifestation)
  • Hematuria
  • Urinary Tract Infections
Intervention  ICMJE
  • Device: Lab Gold Standard
    First intervention (assigned to the "All participants" arm).
  • Device: S-There
    Second intervention (assigned to the "All participants" arm).
Study Arms  ICMJE 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).
Interventions:
  • Device: Lab Gold Standard
  • Device: S-There
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2019)
700
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
250
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Subject cannot collect urine in receptacle.
  • Urinary Catheter
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965975
Other Study ID Numbers  ICMJE S-There Smart Device-2019-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party S-There Technologies SL
Study Sponsor  ICMJE S-There Technologies SL
Collaborators  ICMJE
  • Asociación Instituto de Investigación Sanitaria BioCruces
  • Hospital de Cruces
Investigators  ICMJE Not Provided
PRS Account S-There Technologies SL
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP