RECRUITING

AERA Pediatrics Registry

Description

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

Study Overview

Study Details

Study overview

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

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

AERA Pediatrics Registry

Condition
Dysfunction of Eustachian Tube
Intervention / Treatment

-

Contacts and Locations

West Bloomfield

Michigan Pediatric ENT Associates, West Bloomfield, Michigan, United States, 48322

Fort Worth

Ear and Sinus Institute, Fort Worth, Texas, United States, 76104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age \<18
  • 2. Specific indications for ETBD are documented
  • 3. ETBD with AERA device attempted-
  • 1. ETBD with device other than AERA®
  • 2. Previous ETBD procedure-

Ages Eligible for Study

to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Integra LifeSciences Corporation,

Christopher Schutt, MD, STUDY_DIRECTOR, Acclarent, an Integra LifeSciences Company

Study Record Dates

2031-02