Summative Evaluation to Validate the LEAFix Device With U... | NCT05255432

Studies
Summative Evaluation to Validate the LEAFix Device With Users

NCT05255432

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Status

Unknown status

Last Update Posted

May 11, 2022Actual

Enrollment

32Estimated

Phase

Not provided

Conditions

Anesthesia

Interventions

nil intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2022Estimated

Primary Completion Date

Aug 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Feb 16, 2022

First Submission Date that Met QC Criteria

Feb 16, 2022

First Posted Date

Feb 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2022

Last Update Posted Date

May 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Selection of tasks	Other: nil intervention
Group B		Selection of tasks	Other: nil intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nil intervention	Other	Users observation using medical device on manakin, different scenarios per group	Group A Group B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Member of staff trained in placing airways

Exclusion Criteria:

Previous knowledge of the device

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Practioners who perform airway placement

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Richard Ramsaran, MBChB	Contact	07709674876		richard.ramsaran@liverpoolft.nhs.uk

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided