AERA Pediatrics Registry
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
| Condition(s) | Dysfunction of Eustachian Tube |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients |
| Who can participate | 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- |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Integra LifeSciences Corporation |
| Locations | Palo Alto, California, United States; West Bloomfield, Michigan, United States; Minneapolis, Minnesota, United States; Cincinnati, Ohio, United States; Philadelphia, Pennsylvania, United States; Fort Worth, Texas, United States |
| Start date | 2025-06-17 |
| NCT ID | NCT07071298 |
| Official listing | https://clinicaltrials.gov/study/NCT07071298 |