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Status unknownNCT03965975STSD-2019-001Updated Dec 5, 2019

Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device

An interventional study of Lab Gold Standard and S-There in Renal Insufficiency, Chronic, Heart Failure and Diabete Mellitus, sponsored by S-There Technologies SL. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-05.

Sponsored by S-There Technologies SL · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Insufficiency, Chronic
  • Heart Failure
  • Diabete Mellitus
  • Diabetes; Nephropathy (Manifestation)
  • Hematuria
  • Urinary Tract Infections
03

In context

Urinary Tract Infections

753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.

This study's planned enrollment of 700 is above the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

This is the only study on the registry with S-There Technologies SL as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Subject cannot collect urine in receptacle.
  • Urinary Catheter
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
700 participants (estimated)

Study arms

  • Other
    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).

    Device: Lab Gold Standard · Device: S-There

Interventions

  • DeviceLab Gold Standard

    First intervention (assigned to the "All participants" arm).

  • DeviceS-There

    Second intervention (assigned to the "All participants" arm).

06

What researchers measure

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.

    Time frame: Through study completion, an average of 1 month

07

Study locations

1 of 1 sites recruiting
  • Hospital de Cruces
    Barakaldo, Bizkaia 48903, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03965975
Lead sponsor
S-There Technologies SL
Collaborators
Biocruces Bizkaia Health Research Institute, Hospital de Cruces
Responsible party
Sponsor
First posted
May 29, 2019
Start date
Jun 10, 2019
Primary completion
Mar 2020 (estimated)
Completion
Mar 2020 (estimated)
Last update
Dec 5, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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