Recruiting NCT07071298
AERA Pediatrics Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dysfunction of Eustachian Tube. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
Overview
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
Primary outcome measures
- Failure-free after ETBD with the AERA® device. [Time frame: 27 months]
Secondary outcome measures (6)
- Tympanogram assessed by ear [Time frame: 27 months]
- Pure tone audiometry (PTA) assessed by ear [Time frame: 27 months]
- Valsalva maneuver assessed by ear [Time frame: 27 months]
- Inflammation score assessed by ear [Time frame: 27 months]
- Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient [Time frame: 27 months]
- Otitis Media- 6 Questionnaire (OM-6) assessed by patient [Time frame: 27 months]
Eligibility criteria
Inclusion criteria
- Age <18
- Specific indications for ETBD are documented
- ETBD with AERA device attempted-
Exclusion criteria
- ETBD with device other than AERA®
- Previous ETBD procedure-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 9 centers
- Stanford University — Palo Alto
- Boston Children's Hospital — Boston
- Michigan Pediatric ENT Associates — West Bloomfield
- Children's Minnesota — Minneapolis
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Children's Hospital of Philadelphia — Philadelphia
- Ear and Sinus Institute — Fort Worth
- Texas Children's Hospital — Houston
- … and 1 more center
Identifiers
NCT: NCT07071298 · C-AERA-P-001