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A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Stanford University
Palo Alto, California, United States
Michigan Pediatric ENT Associates
West Bloomfield, Michigan, United States
Children's Minnesota
Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Ear and Sinus Institute
Fort Worth, Texas, United States
Start Date
June 17, 2025
Primary Completion Date
October 1, 2030
Completion Date
February 1, 2031
Last Updated
January 2, 2026
300
ESTIMATED participants
Lead Sponsor
Integra LifeSciences Corporation
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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