AERA Pediatrics Registry
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Integra LifeSciences Corporation
- Study ID
- NCT07071298
- Status
- Recruiting
Conditions
- Dysfunction of Eustachian Tube
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 18 Years
- Healthy Volunteers
- Not accepted
Study Details
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
Key Dates
- Start date
- Jun 17, 2025
- Status verified
- Dec 2025
- Primary completion
- Oct 31, 2030
- Completion
- Feb 28, 2031
Study Design
- Enrollment
- 300 participants (estimated)
Primary Outcome Measure
Failure-free after ETBD with the AERA® device. [ Time Frame: 27 months ]
Central Contacts
- Ashley Ellis17817248422
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | Andrea Miranda Kay Chang (PRINCIPAL_INVESTIGATOR) |
| Michigan Pediatric ENT Associates | West Bloomfield | Michigan | 48322 | Prasad Thottam, DO, FAAP (PRINCIPAL_INVESTIGATOR) |
| Children's Minnesota | Minneapolis | Minnesota | 55404 | Asitha Jayawardena, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Michael DeMarcantonio (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Ashley Williams Ken Kazahaya (PRINCIPAL_INVESTIGATOR) |
| Ear and Sinus Institute | Fort Worth | Texas | 76104 | Marc Dean, M.D. (PRINCIPAL_INVESTIGATOR) |