HematuriaHEMAPOCHENCT03408288
Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.
An observational study of Hematuria, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematuria
- What is being tested?
- Hemapoche, Hemastick and Color description
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2018to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nurses volunteering to take part in the study outside of the urology department of CHU Nimes and a panel of urologist experts
Who may be able to join
- 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
Who cannot join
- The participant has color-blindness
- Nurse or urologist from the urology department of Nimes
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hematuria
- Being tested
- Hemapoche, Hemastick, Color description
- Medical subject headings
- Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemapocheOther
Use of Hemapoche scale to assess hematuria in reference samples
HemastickOther
Use of Hemastick scale to assess hematuria in reference samples
Color descriptionOther
Describe color of reference sample
| Study group | Role | What they receive |
|---|---|---|
| Nurses | Not described Receives: Other: Hemapoche; Other: Hemastick; Other: Color description | |
| Urologists | Not described Receives: Other: Hemapoche; Other: Hemastick; Other: Color description |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-user concordance in assessment of hematuria score measured by Hemapoche
Kappa coefficient
Measured: Baseline
Intra-user concordance in assessment of hematuria score measured by Hemostick
Kappa coefficient
Measured: Baseline
Intra-user concordance in assessment of hematuria described by color of urine
Kappa coefficient
Measured: Baseline
Secondary outcomes (8)
Concordance between nurses versus doctors in assessment of hematuria score measured by Hemapoche
Kappa coefficient
Measured: Baseline
Concordance between nurses versus doctors in assessment of hematuria score measured by Hemastick
Kappa coefficient
Measured: Baseline
Concordance between nurses versus doctors in assessment of hematuria described by color
Kappa coefficient
Measured: Baseline
Time needed to characterize hematuria when using Hemapoche
Seconds (less than one minute)
Measured: Baseline
Time needed to characterize hematuria when using Hemostick
Seconds (less than one minute)
Measured: Baseline
Time needed to characterize hematuria when using color description
Seconds (less than one minute)
Measured: Baseline
Satisfaction of medical staff in using Hemapoche medical device
Visual analog scale (0-10)
Measured: Baseline
Usability scale of Hemapoche device according to medical staff
System usability scale (0-10)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start16 Jan 2018
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armand Chevrot, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408288
- Sponsor's protocol ID
- NIMAO/2017-02/AC-01
- Acronym
- HEMAPOCHE
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.
- ClinicalTrials.gov ID
- NCT03408288
- Acronym / sponsor ID
- HEMAPOCHE / NIMAO/2017-02/AC-01
- Conditions
- Hematuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurses | – | Other: Hemapoche, Other: Hemastick, Other: Color description |
| Urologists | – | Other: Hemapoche, Other: Hemastick, Other: Color description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nurses volunteering to take part in the study outside of the urology department of CHU Nimes and a panel of urologist experts
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- The participant has color-blindness
- Nurse or urologist from the urology department of Nimes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemapocheUse of Hemapoche scale to assess hematuria in reference samples | Other | Nurses, Urologists |
| HemastickUse of Hemastick scale to assess hematuria in reference samples | Other | Nurses, Urologists |
| Color descriptionDescribe color of reference sample | Other | Nurses, Urologists |
Primary outcome
Intra-user concordance in assessment of hematuria score measured by Hemapoche
Time frame: Baseline
Kappa coefficient
Intra-user concordance in assessment of hematuria score measured by Hemostick
Time frame: Baseline
Kappa coefficient
Intra-user concordance in assessment of hematuria described by color of urine
Time frame: Baseline
Kappa coefficient
8 secondary outcomes
Concordance between nurses versus doctors in assessment of hematuria score measured by Hemapoche
Time frame: Baseline
Concordance between nurses versus doctors in assessment of hematuria score measured by Hemastick
Time frame: Baseline
Concordance between nurses versus doctors in assessment of hematuria described by color
Time frame: Baseline
Time needed to characterize hematuria when using Hemapoche
Time frame: Baseline
Time needed to characterize hematuria when using Hemostick
Time frame: Baseline
Time needed to characterize hematuria when using color description
Time frame: Baseline
Satisfaction of medical staff in using Hemapoche medical device
Time frame: Baseline
Usability scale of Hemapoche device according to medical staff
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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Hematuria - Cause Not Known
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armand Chevrot, MD principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematuria, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-user concordance in assessment of hematuria score measured by Hemapoche (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.