AERA device registry for children with Eustachian tube dysfunction
Official title: A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
Run by Integra LifeSciences Corporation · NCT07071298 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Integra LifeSciences Corporation Industry-sponsored |
| Locations | 9 sites (Palo Alto, California and 8 other locations) |
| Status | Recruiting |
| Started | June 17, 2025 |
| Main results expected | October 2030 |
| Study ends | February 2031 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07071298 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Stanford University
Palo Alto, California, United States Recruiting -
Boston Children's Hospital
Boston, Massachusetts, 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
Show 3 more locations
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Ear and Sinus Institute
Fort Worth, Texas, United States Recruiting -
Texas Children's Hospital
Houston, Texas, United States Recruiting -
University of Utah
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Ashley Ellis
- Email: ashley.ellis@integralife.com
- Phone: 17817248422
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.