AERA Pediatrics Registry

Recruiting

• Conditions: Dysfunction of Eustachian Tube

• Registration Number: NCT07071298
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-17
• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-20
• Primary Completion: 2030-10
• Study Completion: 2031-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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-

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure-free after ETBD with the AERA® device.	27 months	Failure is defined as revision ETD surgery (e.g. further ETBD, tympanostomy tube (TT) insertion, or adenoidectomy for ETD).

Secondary Outcome Measures

Name	Time	Method
Tympanogram assessed by ear	27 months	Tympanogram
Pure tone audiometry (PTA) assessed by ear	27 months	Pure tone audiometry (PTA)
Valsalva maneuver assessed by ear	27 months	Valsalva maneuver
Inflammation score assessed by ear	27 months	Score 1-4. The higher the score, the worse the outcome.
Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient	27 months	Total score of 7-49. The higher the score, the worse the outcome.
Otitis Media- 6 Questionnaire (OM-6) assessed by patient	27 months	Total score 6-42. The higher the score, the worse the outcome.

Trial Locations

Locations (2)

Michigan Pediatric ENT Associates; 🇺🇸 West Bloomfield, Michigan, United States

Ear and Sinus Institute; 🇺🇸 Fort Worth, Texas, United States