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
Stanford University
Palo Alto 5380748, California 5332921 94304
Palo Alto 5380748, California 5332921 94304
Michigan Pediatric ENT Associates
West Bloomfield 7259621, Michigan 5001836 48322
West Bloomfield 7259621, Michigan 5001836 48322
Children's Minnesota
Minneapolis 5037649, Minnesota 5037779 55404
Minneapolis 5037649, Minnesota 5037779 55404
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
Cincinnati 4508722, Ohio 5165418 45229
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Ear and Sinus Institute
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
More Details
- NCT ID
- NCT07071298
- Status
- Recruiting
- Sponsor
- Integra LifeSciences Corporation