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CompletedNCT03408288HEMAPOCHEUpdated Jul 3, 2018

Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.

An observational study in Hematuria, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

The investigators hypothesize that incorporation of a colorimetric scale on urine collection bags to estimate degree of hematuria would allow better characterization of urine by healthcare staff thus leading to improved patient care.

02

Conditions studied

  • Hematuria

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03

In context

Hematuria

67 studies on the registry are indexed under Hematuria; 17 are open to participants now.

This study's enrollment of 20 is below the median of 500 across 31 observational studies indexed under Hematuria.

Browse Hematuria studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Browse Centre Hospitalier Universitaire de Nīmes studies →

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
Sampling method
Non-probability sample

Study population

Nurses volunteering to take part in the study outside of the urology department of CHU Nimes and a panel of urologist experts

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The participant is at least 18 year old
  • Nurses recruited voluntarily in the CHU Nimes outside of the Urology department of any duration of experience
  • Urologist working in the Languedoc-Roussillon region

Exclusion criteria

Exclusion Criteria:

  • The participant has color-blindness
  • Nurse or urologist from the urology department of Nimes
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Nurses

    Other: Hemapoche · Other: Hemastick · Other: Color description

  • Urologists

    Other: Hemapoche · Other: Hemastick · Other: Color description

Interventions

  • OtherHemapoche

    Use of Hemapoche scale to assess hematuria in reference samples

  • OtherHemastick

    Use of Hemastick scale to assess hematuria in reference samples

  • OtherColor description

    Describe color of reference sample

06

What researchers measure

Primary outcomes

  1. Intra-user concordance in assessment of hematuria score measured by Hemapoche

    Kappa coefficient

    Time frame: Baseline

  2. Intra-user concordance in assessment of hematuria score measured by Hemostick

    Kappa coefficient

    Time frame: Baseline

  3. Intra-user concordance in assessment of hematuria described by color of urine

    Kappa coefficient

    Time frame: Baseline

Secondary outcomes

  1. Concordance between nurses versus doctors in assessment of hematuria score measured by Hemapoche

    Kappa coefficient

    Time frame: Baseline

  2. Concordance between nurses versus doctors in assessment of hematuria score measured by Hemastick

    Kappa coefficient

    Time frame: Baseline

  3. Concordance between nurses versus doctors in assessment of hematuria described by color

    Kappa coefficient

    Time frame: Baseline

  4. Time needed to characterize hematuria when using Hemapoche

    Seconds (less than one minute)

    Time frame: Baseline

  5. Time needed to characterize hematuria when using Hemostick

    Seconds (less than one minute)

    Time frame: Baseline

  6. Time needed to characterize hematuria when using color description

    Seconds (less than one minute)

    Time frame: Baseline

  7. Satisfaction of medical staff in using Hemapoche medical device

    Visual analog scale (0-10)

    Time frame: Baseline

  8. Usability scale of Hemapoche device according to medical staff

    System usability scale (0-10)

    Time frame: Baseline

07

Study locations

1 site
  • CHU Nimes
    Nîmes, 30029, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Feb 2018, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2018
First posted
Jan 24, 2018
StartActual
Jan 16, 2018
Primary completionActual
Feb 1, 2018
CompletionActual
Feb 1, 2018
Last update
Jul 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03408288
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Jan 16, 2018
Primary completion
Feb 1, 2018
Completion
Feb 1, 2018
Last update
Jul 3, 2018

Study contacts

Armand Chevrot, MD
principal investigator · CHU Nimes

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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