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Detection of Usability Errors of a Medical Device Zeneo®

NCT03808246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • National Research Agency, France

    collaborator OTHER

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Romaric Marcilly, PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2019-12-09
Completion
2019-12-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03808246 on ClinicalTrials.gov