NCT Number: NCT07071298
AERA Pediatrics Registry
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
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Request InfoKey information
Conditions
Age range
Up to 18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Stanford University, Palo Alto, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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-
Treatment and study plan
Primary outcomes
-
Failure-free after ETBD with the AERA® device.
Time frame: 27 months
Failure is defined as revision ETD surgery (e.g. further ETBD, tympanostomy tube (TT) insertion, or adenoidectomy for ETD).
Secondary outcomes
-
Tympanogram assessed by ear
Time frame: 27 months
Tympanogram
-
Pure tone audiometry (PTA) assessed by ear
Time frame: 27 months
Pure tone audiometry (PTA)
-
Valsalva maneuver assessed by ear
Time frame: 27 months
Valsalva maneuver
-
Inflammation score assessed by ear
Time frame: 27 months
Score 1-4. The higher the score, the worse the outcome.
-
Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient
Time frame: 27 months
Total score of 7-49. The higher the score, the worse the outcome.
-
Otitis Media- 6 Questionnaire (OM-6) assessed by patient
Time frame: 27 months
Total score 6-42. The higher the score, the worse the outcome.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Integra LifeSciences Corporation
Industry
Registry information
Official study title
A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
Important dates
- Study start
- 2025
- Primary completion
- 2030
- Study completion
- 2031
- First posted
- Jul 17, 2025
- Registry last updated
- Jul 7, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.