Summative Evaluation to Validate the LEAFix Device With Users

Summative Evaluation to Validate That the Laryngeal, Endo-tracheal, Airway Fixator (LEAFix) Can be Used Safely and Effectively by Intended Users to Secure Airway Devices

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05255432

Acronym

LEAFIXUser

Enrollment

Registered

2022-02-24

Start date

2022-06-30

Completion date

2022-09-30

Last updated

2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

OTHERnil intervention

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Member of staff trained in placing airways

Exclusion criteria

* Previous knowledge of the device

Design outcomes

Primary

Measure	Time frame	Description
Performance of user against the predetermined standard	1 hour	The users will be marked against a standard set to look for problems

Contacts

Primary ContactRichard Ramsaran, MBChB

richard.ramsaran@liverpoolft.nhs.uk07709674876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026