RecruitingNCT07071298

AERA Pediatrics Registry

A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System


Sponsor

Integra LifeSciences Corporation

Enrollment

300 participants

Start Date

Jun 17, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients


Eligibility

Max Age: 18 Years

Inclusion Criteria3

  • Age <18
  • Specific indications for ETBD are documented
  • ETBD with AERA device attempted-

Exclusion Criteria2

  • ETBD with device other than AERA®
  • Previous ETBD procedure-

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Locations(6)

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

View Full Details on ClinicalTrials.gov

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NCT07071298