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Summative Evaluation to Validate the LEAFix Device With Users

NCT05255432 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2022-05-11

No results posted yet for this study

Summary

The Laryngeal Endo-tracheal Airway Fixator(LEAFix) is a single use product designed to secure airway devices to patients during anaesthesia, with better infection control management and interaction with the patients skin. This study investigates the users of the LEAFix device interacting with the LEAFix device, its packaging and a simulated patient through different scenarios of securing an airway device. The aim is to understand the risks associated with the use of the device for CE marking purposes. This study is funded by Innovel Ltd. the manufacturer of the device.

Conditions

  • Anesthesia

Interventions

OTHER

nil intervention

Users observation using medical device on manakin, different scenarios per group

Sponsors & Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-08-31
Completion
2022-09-30

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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 NCT05255432 on ClinicalTrials.gov