AERA device registry for children with Eustachian tube dysfunction
A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
This registry will collect real-world information to see how the AERA balloon device works in children under 18 who have Eustachian tube dysfunction and who undergo an attempted ETBD with the AERA device.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Integra LifeSciences Corporation Industry-sponsored |
| Locations | 6 sites (Palo Alto, California and 5 other locations) |
| Trial ID | NCT07071298 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, observational registry collecting real-world evidence on the clinical performance of the AERA device when used for balloon dilation of the Eustachian tube in pediatric patients. Eligible participants are children under 18 with documented indications for ETBD who undergo an attempted ETBD with the AERA device, while those who receive a different device or have prior ETBD are excluded. Participating U.S. centers include Stanford University, Michigan Pediatric ENT Associates, and Children's Minnesota, and the registry is sponsored by Integra LifeSciences Corporation. The registry will capture procedural details, clinical outcomes, and device-related safety events to confirm continued device performance in routine pediatric practice.
Who should consider this trial
Good fit: Children under 18 with documented indications for Eustachian tube balloon dilation who are undergoing their first ETBD attempt with the AERA device are ideal candidates.
Not a fit: Patients who receive a different ETBD device, have had a prior ETBD procedure, are adults, or do not meet the documented indication may not receive benefit from enrollment.
Why it matters
Potential benefit: If successful, the registry could confirm the AERA device's safety and performance in real-world pediatric use, supporting clinician decision-making and patient care.
How similar studies have performed: Balloon dilation of the Eustachian tube has prior supportive data from adult and pediatric series, but device-specific pediatric registries like this provide additional real-world evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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-
Where this trial is running
Palo Alto, California and 5 other locations
- Stanford University — Palo Alto, California, United States (Recruiting)
- Michigan Pediatric ENT Associates — West Bloomfield, Michigan, United States (Recruiting)
- Children's Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Ear and Sinus Institute — Fort Worth, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Ashley Ellis
- Email: ashley.ellis@integralife.com
- Phone: 17817248422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.