Study detail
Recruiting
A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
Integra LifeSciences Corporation
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
- Age range
- Up to 18 years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: 1. Age \<18 2. Specific indications for ETBD are documented 3. ETBD with AERA device attempted- Exclusion Criteria: 1. ETBD with device other than AERA® 2. Previous ETBD procedure-
Locations (6)
- Stanford UniversityPalo Alto, California
- Michigan Pediatric ENT AssociatesWest Bloomfield, Michigan
- Children's MinnesotaMinneapolis, Minnesota
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- Ear and Sinus InstituteFort Worth, Texas