AERA Pediatrics Registry

Launched by INTEGRA LIFESCIENCES CORPORATION · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well the AERA® device works for children with problems related to the Eustachian tube, which is a small passage that helps equalize ear pressure and drain fluid. The study is collecting real-world information from multiple centers to see how the device performs in everyday use. It is currently open and looking for participants under the age of 18 who have a clear reason to try Eustachian tube balloon dilation (ETBD) using the AERA® device.

Children who have already had this procedure done with the AERA® device and meet the specific medical reasons for ETBD may be eligible to join. However, children who have had ETBD with a different device or have had the procedure before are not included. If your child participates, doctors will observe and record how the device works during their treatment without changing their usual care. This study helps gather important information to make sure this treatment is safe and effective for kids who need it.

Gender

ALL

Eligibility 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-