AERA Pediatrics Registry

Integra LifeSciences

Status: Enrolling

Conditions: Dysfunction of Eustachian Tube

Study type: Observational

Funder types: Industry

Identifiers

NCT07071298

C-AERA-P-001

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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-