Summative Evaluation to Validate the LEAFix Device With Users
LEAFIXUser
1 other identifier
observational
32
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMay 11, 2022
May 1, 2022
2 months
February 16, 2022
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Performance of user against the predetermined standard
The users will be marked against a standard set to look for problems
1 hour
Study Arms (2)
Group A
Selection of tasks
Group B
Selection of tasks
Interventions
Users observation using medical device on manakin, different scenarios per group
Eligibility Criteria
Practioners who perform airway placement
You may qualify if:
- Member of staff trained in placing airways
You may not qualify if:
- Previous knowledge of the device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 24, 2022
Study Start
June 1, 2022
Primary Completion
August 1, 2022
Study Completion
September 1, 2022
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share