AERA Pediatrics Registry
ConditionDysfunction of Eustachian Tube
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorIntegra LifeSciences Corporation
About this trial
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age <18
Specific indications for ETBD are documented
ETBD with AERA device attempted-
Disqualifiers
ETBD with device other than AERA®
Previous ETBD procedure-
Trial population
Subjects under the age of 18 with ETD who are treated with the AERA® device
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Failure-free after ETBD with the AERA® device.
Failure is defined as revision ETD surgery (e.g. further ETBD, tympanostomy tube (TT) insertion, or adenoidectomy for ETD).
Time frame
27 monthsSecondary outcomes
1
Tympanogram assessed by ear
Tympanogram
Time frame
27 months2
Pure tone audiometry (PTA) assessed by ear
Pure tone audiometry (PTA)
Time frame
27 months3
Valsalva maneuver assessed by ear
Valsalva maneuver
Time frame
27 months4
Inflammation score assessed by ear
Score 1-4. The higher the score, the worse the outcome.
Time frame
27 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov