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Search / Trial NCT06659796

LifeVac Survey Study

Launched by LIFEVAC, LLC · Oct 24, 2024

Trial Information

Current as of August 02, 2025

Completed

Keywords

Airway Obstruction Choking

ClinConnect Summary

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. Th...

Gender

ALL

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

About Lifevac, Llc

LifeVac, LLC is a pioneering medical device company dedicated to developing innovative solutions for emergency airway management. Specializing in non-invasive suction devices, LifeVac aims to enhance life-saving interventions during choking incidents. Committed to rigorous research and clinical validation, the company collaborates with healthcare professionals and institutions to ensure the efficacy and safety of its products. By prioritizing patient outcomes and advancing emergency response protocols, LifeVac, LLC strives to reduce choking-related fatalities and improve public health awareness.

Locations

Dedham, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Andrea Nadai

Principal Investigator

Boston MedTech Advisors

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported