Status:
COMPLETED
Detection of Usability Errors of a Medical Device Zeneo®
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
National Research Agency, France
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 al...
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 t...
Eligibility Criteria
Inclusion
- Two types of participants (healthy people) will be recruited: participants informed about auto-injector pens (BUT NOT PATIENTS) and participants naïves on this topic.
- 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 -
Exclusion
- Pregnant women
- Vulnerable Persons
- Persons under administrative supervision
- Persons who are subject to a judicial protection measure
- Persons who do not understand correctly French.
Key Trial Info
Start Date :
April 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03808246
Start Date
April 24 2019
End Date
December 9 2019
Last Update
March 26 2020
Active Locations (1)
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1
Usability Lab of CIC IT 1403
Lille, Haut de France, France, 59037