LifeVac Survey Study

NCT06659796 | Completed FDA Device

• 1 other identifier: 2024-001
• Study Type: observational
• Target: 2,930
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Airway Obstruction; Choking

Keywords

Airway obstruction; Choking

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• Secondary Safety Endpoint

  Up to 1 week

• Secondary Effectiveness Endpoint

  Up to 1 week

Study Arms (1)

Users of LifeVac device

Individuals who have used the LifeVac device during a choking emergency

Device: LifeVac

Interventions

LifeVac DEVICE

Removal of airway obstruction during choking emergency

Users of LifeVac device

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeVac, LLC: lead

Study Sites (1)

Boston MedTech Advisors

Dedham, Massachusetts, 02026, United States

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Andrea Nadai

  Boston MedTech Advisors

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: June 24, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)