Back to resultsClinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device (STSD-2019-001)
Primary Purpose
Renal Insufficiency, Chronic, Heart Failure, Diabete Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lab Gold Standard
S-There
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Insufficiency, Chronic
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
Sites / Locations
- Hospital de CrucesRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All participants (single arm)
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03965975
First Posted
May 24, 2019
Last Updated
December 4, 2019
Sponsor
S-There Technologies SL
Collaborators
Biocruces Bizkaia Health Research Institute, Hospital de Cruces
1. Study Identification
Unique Protocol Identification Number
NCT03965975
Brief Title
Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device
Acronym
STSD-2019-001
Official Title
(In Spanish, Spain) "Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device"
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S-There Technologies SL
Collaborators
Biocruces Bizkaia Health Research Institute, Hospital de Cruces
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Heart Failure, Diabete Mellitus, Diabetes; Nephropathy (Manifestation), Hematuria, Urinary Tract Infections
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All participants (single arm)
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Lab Gold Standard
Intervention Description
First intervention (assigned to the "All participants" arm).
Intervention Type
Device
Intervention Name(s)
S-There
Intervention Description
Second intervention (assigned to the "All participants" arm).
Primary Outcome Measure Information:
Title
Accuracy to compared device
Description
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.
Time Frame
Through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nefrología Servicio, Unit
Phone
946006000
Email
eider@s-there.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device
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