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OpenTrials
Completed

NCT Number: NCT03808246

Detection of Usability Errors of a Medical Device Zeneo®

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Usability Lab of CIC IT 1403

Lille, Haut de France, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

using the demo version of a self-injector pen

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. number of use errors uncovered per participant

    Time frame: through study completion, an average of 6 months

  2. number of participants who detected a given error

    Time frame: through study completion, an average of 6 months

  3. number of unanticipated errors detected

    Time frame: through study completion, an average of 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • National Research Agency, France

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2019
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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