LifeVac Survey Study | NCT06659796

Studies
LifeVac Survey Study

NCT06659796

Sponsor

LifeVac, LLC

Status

Completed

Last Update Posted

Jul 18, 2025Actual

Enrollment

2,930Actual

Phase

Not provided

Conditions

Airway Obstruction
Choking

Interventions

LifeVac

Countries

United States

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2024Actual

Primary Completion Date

Jan 31, 2025Actual

Completion Date

Jan 31, 2025Actual

First Submitted Date

Oct 21, 2024

First Submission Date that Met QC Criteria

Oct 24, 2024

First Posted Date

Oct 26, 2024Actual

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

Jul 15, 2025

Last Update Posted Date

Jul 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational, non-interventional survey study is intended to explore user experiences with the LifeVac airway clearance device, with a particular emphasis on real-world application in choking emergencies in the USA. This study seeks to gather valuable insights from a representative sample of the LifeVac device purchaser base.

The main questions the study aims to answer are:

Is the LifeVac device safe for individuals experiencing a choking emergency?
Is the LifeVac device successful in removing an obstruction during a choking incident?

Participants: Purchasers of the LifeVac device.

Detailed Description

Foreign Body Airway Obstruction (FBAO), commonly referred to as choking, occurs when an aspirated solid or semisolid object becomes lodged in a person's larynx or trachea. If the object is large enough it may cause the complete (or near complete) obstruction of the airway. Without oxygen, brain damage can occur in as soon as four minutes following the event.

LifeVac is a non-powered, non-invasive, single-use airway clearance device developed for resuscitating a victim with an airway obstruction when current choking protocols (basic life support [BLS]) failed to remove the obstruction. The device is intended be used on adults and children, in home and non-home settings, and can be administered by professional/HCP users or laypersons without professional training in a choking emergency.

This observational, non-interventional survey study will be conducted on purchasers of the LifeVac device. The study intends to obtain responses from at least 26 users of the device in each of the two age groups of interest, individuals up to 19 years of age (pediatric) and above 20 years of age (adult), and capture unbiased information on the device users' experience, regardless of its outcome.

Objectives:

Gather information on device usage patterns and user experiences with the LifeVac airway clearance device.
Collect data on the safety and effectiveness of the device in real-world choking interventions.

Target Population:

Purchasers of the LifeVac device in the USA from 2015 to April 2024.

Data Collection Procedure:

Purchasers will be invited to participate via a standardized email with a link to an online platform (IntelliSurvey, Inc.) independent of the device manufacturer.
Participation will require electronic consent before accessing the survey.
The survey is accessible through a web browser and can be completed on a desktop computer or mobile device.

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

2,930Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Users of LifeVac device		Individuals who have used the LifeVac device during a choking emergency	Device: LifeVac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LifeVac	Device	Removal of airway obstruction during choking emergency	Users of LifeVac device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Safety Endpoint	Occurrence of any serious adverse events (SAE) associated with the use of the LifeVac device.	Up to 1 week
Primary Effectiveness Endpoint	Confirm success or partial success in relieving airway obstruction in at least 80% of uses of the device.	Up to 1 week

Secondary Outcomes

Measure	Description	Time Frame
Secondary Safety Endpoint	Occurrence of any adverse events (AE) associated with the use of the LifeVac device.	Up to 1 week
Secondary Effectiveness Endpoint	Explore potential correlations between the outcome of the device use with age of the choking person, the nature of the obstruction, and the environment where the choking incident transpired.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Purchases of the LifeVac device Original database: all purchasers of the LifeVac device from the LifeVac website starting in 2015 until April 2024, a timeframe that yields a database of above 450,000 individuals with no email duplications and third party suppliers.

Survey batches: randomly selected sample of 50,000 purchasers (10% of the database).

Number of batches required will be based on response rate.

English speaking
Ability to understand and accept the consent form

Exclusion Criteria:

Did not purchase a LifeVac device
Third party suppliers
Non-English speakers (as LifeVac labeling and survey materials are only available in English)
Unwilling or unable to accept the consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

• Purchasers of the LifeVac device in the USA from 2015 to April 2024

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Nadai	Boston MedTech Advisors	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston MedTech Advisors		Dedham	Massachusetts	02026	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D000402	Airway Obstruction

Ancestor Terms

ID	Term
D012131	Respiratory Insufficiency
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided