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RecruitingNCT07071298Updated Jul 7, 2026

AERA Pediatrics Registry

An observational study in Dysfunction of Eustachian Tube, sponsored by Integra LifeSciences Corporation. Recruiting at 9 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Integra LifeSciences Corporation · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
Up to 18 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Dysfunction of Eustachian Tube

Keywords

  • ETBD
03

In context

Lead sponsor

Integra LifeSciences Corporation is the lead sponsor of 82 studies on the registry; 5 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Browse Integra LifeSciences Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects under the age of 18 with ETD who are treated with the AERA® device

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age \<18
  2. Specific indications for ETBD are documented
  3. ETBD with AERA device attempted-

Exclusion criteria

Exclusion Criteria:

  1. ETBD with device other than AERA®
  2. Previous ETBD procedure-
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
27 Months
Patient registry
Yes
06

What researchers measure

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 months

Secondary outcomes

  1. Tympanogram assessed by ear

    Tympanogram

    Time frame: 27 months

  2. Pure tone audiometry (PTA) assessed by ear

    Pure tone audiometry (PTA)

    Time frame: 27 months

  3. Valsalva maneuver assessed by ear

    Valsalva maneuver

    Time frame: 27 months

  4. Inflammation score assessed by ear

    Score 1-4. The higher the score, the worse the outcome.

    Time frame: 27 months

  5. Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient

    Total score of 7-49. The higher the score, the worse the outcome.

    Time frame: 27 months

  6. Otitis Media- 6 Questionnaire (OM-6) assessed by patient

    Total score 6-42. The higher the score, the worse the outcome.

    Time frame: 27 months

07

Study locations

9 of 9 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Oct 2030, 64 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2025
First posted
Jul 17, 2025
StartActual
Jun 17, 2025
Primary completionEst.
Oct 2030
CompletionEst.
Feb 2031
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07071298
Lead sponsor
Integra LifeSciences Corporation
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Jun 17, 2025
Primary completion
Oct 2030 (estimated)
Completion
Feb 2031 (estimated)
Last update
Jul 7, 2026

Study contacts

Ashley Ellis
Contact
ashley.ellis@integralife.com
17817248422
Christopher Schutt, MD
study director · Acclarent, an Integra LifeSciences Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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