AERA Pediatrics Registry
Purpose
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
Condition
- Dysfunction of Eustachian Tube
Eligibility
- Eligible Ages
- Under 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age <18 2. Specific indications for ETBD are documented 3. ETBD with AERA device attempted-
Exclusion Criteria
- ETBD with device other than AERA® 2. Previous ETBD procedure-
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Recruiting Locations
Michigan Pediatric ENT Associates
West Bloomfield, Michigan 48322
West Bloomfield, Michigan 48322
More Details
- NCT ID
- NCT07071298
- Status
- Recruiting
- Sponsor
- Integra LifeSciences Corporation