Detection of Usability Errors of a Medical Device Zeneo®

Healthy Volunteers Clinical Trial

Official title:

Detection of Usability Errors of a Medical Device Zeneo®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808246
• Other study ID #: 2017_16
• Secondary ID: 2017-A02847-46
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Two types of participants (healthy people) will be recruited: participants informed about auto-injector pens (BUT NOT PATIENTS) and participants naïves on this topic.

Inclusion Criteria:

• 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 Criteria:

• Pregnant women

• Vulnerable Persons

• Persons under administrative supervision

• Persons who are subject to a judicial protection measure

• Persons who do not understand correctly French.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• using the demo version of a self-injector pen
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.

Locations

Country	Name	City	State
France	Usability Lab of CIC IT 1403	Lille	Haut De France

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For each arm, number of participants needed to uncover 95% of the use errors known		through study completion, an average of 6 months
Secondary	number of use errors uncovered per participant		through study completion, an average of 6 months
Secondary	number of participants who detected a given error		through study completion, an average of 6 months
Secondary	number of unanticipated errors detected		through study completion, an average of 6 months