Dysfunction of Eustachian Tube
Conditions
Keywords
ETBD
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
Interventions
None listed
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTAshley Ellis
STUDY_DIRECTORChristopher Schutt, MD
Acclarent, an Integra LifeSciences Company
Outcome results
None listed