Healthy VolunteersNCT03808246
Detection of Usability Errors of a Medical Device Zeneo®
A study testing using the demo version of a self-injector pen in people with Healthy Volunteers, run by University Hospital, Lille at 1 site in France.
Trial summary
The research addresses the question of the number of participants needed to identify as many usability-induced errors as possible in the context of summative usability tests. The research addresses also the impact of the ecological validity of the test environment on the number of usability-induced errors uncovered. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- using the demo version of a self-injector pen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2019to 9 Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- Able to use the device
- Without previous experience of anaphylactic shock
- Not taking a psychotropic drug
- Without hearing impairment
- Covered by social security
- Who signed the consent form and the information letter
- Who agree to conform to the procedure of the study -
Who cannot join
- Pregnant women
- Vulnerable Persons
- Persons under administrative supervision
- Persons who are subject to a judicial protection measure
- Persons who do not understand correctly French.
Trial locations and contacts
1 site in 1 country.
About this study
The research addresses the question of the number of participants needed to identify as many usability-induced errors as possible in the context of summative usability tests. The research addresses also the impact of the ecological validity of the test environment on the number of usability-induced errors uncovered.
Read the detailed description
In order to determine how many participants must be recruited to detect 95% of the anticipated use errors, two groups of participants (naives or informed to the type of device under evaluation) will take part to usability test of a demo version of an auto injector pen in one of two test environments (realistic or laboratory-like). The combination of the 2 types of users and the two types of environment composes 4 arms.
By default, 15 participants will be recruited per arm (in conformity with usual guidelines). If, in a given group, 95% of anticipated errors are detected, no more participants will be recruited in the arm. Otherwise, 5 other participants will be recruited till the 95% threshold is reached with a maximum of 40 participants per group.
- Conditions
- Healthy Volunteers
- Being tested
- using the demo version of a self-injector pen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using the demo version of a self-injector penOther
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
| Study group | Role | What they receive |
|---|---|---|
| naive/realistic environment | Experimental | This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation.
The intervention is "using the demo version of a self-injector pen". Receives: Other: using the demo version of a self-injector pen |
| informed/realistic environment | Experimental | This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation.
The intervention is "using the demo version of a self-injector pen". Receives: Other: using the demo version of a self-injector pen |
| informed/laboratory-like environment | Experimental | This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation.
The intervention is "using the demo version of a self-injector pen". Receives: Other: using the demo version of a self-injector pen |
| naive/laboratory-like environment | Experimental | This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation.
The intervention is "using the demo version of a self-injector pen". Receives: Other: using the demo version of a self-injector pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each arm, number of participants needed to uncover 95% of the use errors known
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
number of use errors uncovered per participant
Measured: through study completion, an average of 6 months
number of participants who detected a given error
Measured: through study completion, an average of 6 months
number of unanticipated errors detected
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start24 Apr 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 profiles of participants (naïves vs. informed) x 2 types of test environment (realistic vs. laboratory-like). Each participant, depending on her/his profile is assigned to one "profile of participant" group and randomly to one "type of test environment" group.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Romaric Marcilly, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808246
- Sponsor's protocol ID
- 2017_16
- Other IDs
- 2017-A02847-46
- Status last verified
- Mar 2020
- First submitted
- 18 Sep 2018
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caron A, Vandewalle V, Marcilly R, Rochat J, Dervaux B. The Optimal Sample Size for Usability Testing, From the Manufacturer's Perspective: A Value-of-Information Approach. Value Health. 2022 Jan;25(1):116-124. doi: 10.1016/j.jval.2021.07.010. Epub 2021 Aug 28.
PubMed 35031090
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Usability Errors of a Medical Device Zeneo®
- ClinicalTrials.gov ID
- NCT03808246
- Acronym / sponsor ID
- 2017_16
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 17 Jan 2019 (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 research addresses the question of the number of participants needed to identify as many usability-induced errors as possible in the context of summative usability tests. The research addresses also the impact of the ecological validity of the test environment on the number of usability-induced errors uncovered.
Detailed description
In order to determine how many participants must be recruited to detect 95% of the anticipated use errors, two groups of participants (naives or informed to the type of device under evaluation) will take part to usability test of a demo version of an auto injector pen in one of two test environments (realistic or laboratory-like). The combination of the 2 types of users and the two types of environment composes 4 arms.
By default, 15 participants will be recruited per arm (in conformity with usual guidelines). If, in a given group, 95% of anticipated errors are detected, no more participants will be recruited in the arm. Otherwise, 5 other participants will be recruited till the 95% threshold is reached with a maximum of 40 participants per group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2 profiles of participants (naïves vs. informed) x 2 types of test environment (realistic vs. laboratory-like). Each participant, depending on her/his profile is assigned to one "profile of participant" group and randomly to one "type of test environment" group.
| Arm | Type | Receives |
|---|---|---|
| naive/realistic environment | Experimental | Other: using the demo version of a self-injector penThis arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
| informed/realistic environment | Experimental | Other: using the demo version of a self-injector penThis arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
| informed/laboratory-like environment | Experimental | Other: using the demo version of a self-injector penThis arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
| naive/laboratory-like environment | Experimental | Other: using the demo version of a self-injector penThis arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to use the device
- Without previous experience of anaphylactic shock
- Not taking a psychotropic drug
- Without hearing impairment
- Covered by social security
Key exclusion criteria (5 listed)
- Pregnant women
- Vulnerable Persons
- Persons under administrative supervision
- Persons who are subject to a judicial protection measure
- Persons who do not understand correctly French.
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 |
|---|---|---|
| using the demo version of a self-injector penParticipants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock. | Other | informed/laboratory-like environment, informed/realistic environment, naive/laboratory-like environment, naive/realistic environment |
Primary outcome
For each arm, number of participants needed to uncover 95% of the use errors known
Time frame: through study completion, an average of 6 months
3 secondary outcomes
number of use errors uncovered per participant
Time frame: through study completion, an average of 6 months
number of participants who detected a given error
Time frame: through study completion, an average of 6 months
number of unanticipated errors detected
Time frame: through study completion, an average of 6 months
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 22 Apr 2026.
- Results publication: PubMed 35031090Caron A, Vandewalle V, Marcilly R, Rochat J, Dervaux B. The Optimal Sample Size for Usability Testing, From the Manufacturer's Perspective: A Value-of-Information Approach. Value Health. 2022 Jan;25(1):116-124. doi: 10.1016/j.jval.2021.07.010. Epub 2021 Aug 28.
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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.
Romaric Marcilly, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using the demo version of a self-injector pen in people with Healthy Volunteers, run by University Hospital, Lille 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 7 inclusion and 5 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 22 Apr 2026. 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?
For each arm, number of participants needed to uncover 95% of the use errors known (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03808246, which also lists 1 linked publication.
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 22 Apr 2026.