Dysfunction of Eustachian TubeNCT07071298
AERA Pediatrics Registry
An observational study of Dysfunction of Eustachian Tube, run by Integra LifeSciences Corporation at 9 sites in United States.
Trial summary
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Dysfunction of Eustachian Tube
- How many people
- 300 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Jun 2025to Feb 2031
- How long will I take part?
- 27 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects under the age of 18 with ETD who are treated with the AERA® device
Who may be able to join
- Age <18
- Specific indications for ETBD are documented
- ETBD with AERA device attempted-
Who cannot join
- ETBD with device other than AERA®
- Previous ETBD procedure-
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Brynn Lopez, 617-355-6134, brynn.lopez@childrens.harvard.edu
Dennis Poe
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Katie Sawvell, 513-636-4383, Katie.Sawvell@cchmc.org
Michael DeMarcantonio
- Recruiting
Ear and Sinus Institute
Fort Worth, Texas, 76104
Karyn Willyerd, 682-718-1778, kwillyerd@berksonmedical.com
Marc Dean, M.D.
- Recruiting
Texas Children's Hospital
Houston, Texas, 77401
Sadaf Batla, Sadaf.Batla@bcm.edu
Yi-Chun Liu
- Recruiting
Children's Minnesota
Minneapolis, Minnesota, 55404
Stacey Rabusch, 651-253-6724, Stacey.Rabusch@childrensmn.org
Asitha Jayawardena, MD, MPH
- Recruiting
Stanford University
Palo Alto, California, 94304
Andrea Miranda, andream7@stanford.edu
Kay Chang
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Ashley Williams, Williamsab@chop.edu
Ken Kazahaya
- Recruiting
University of Utah
Salt Lake City, Utah, 84113
Sarah Al Nemer, u1115482@utah.edu
Albert Park, MD
- Recruiting
Michigan Pediatric ENT Associates
West Bloomfield, Michigan, 48322
Amanda West, 248-270-6059, amandaw@mpenta.org
Prasad Thottam, DO, FAAP
About this study
Official title: A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
- Conditions
- Dysfunction of Eustachian Tube
- Keywords
- ETBD
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 27 months
Secondary outcomes (6)
Tympanogram assessed by ear
Tympanogram
Measured: 27 months
Pure tone audiometry (PTA) assessed by ear
Pure tone audiometry (PTA)
Measured: 27 months
Valsalva maneuver assessed by ear
Valsalva maneuver
Measured: 27 months
Inflammation score assessed by ear
Score 1-4. The higher the score, the worse the outcome.
Measured: 27 months
Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient
Total score of 7-49. The higher the score, the worse the outcome.
Measured: 27 months
Otitis Media- 6 Questionnaire (OM-6) assessed by patient
Total score 6-42. The higher the score, the worse the outcome.
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start17 Jun 2025
- Primary completionOct 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunction of Eustachian TubeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 27 Months
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Schutt, MD, Study director, Acclarent, an Integra LifeSciences Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071298
- Sponsor's protocol ID
- C-AERA-P-001
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
- ClinicalTrials.gov ID
- NCT07071298
- Acronym / sponsor ID
- C-AERA-P-001
- Conditions
- Dysfunction of Eustachian Tube
- Keywords
- ETBD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 27 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects under the age of 18 with ETD who are treated with the AERA® device
Key inclusion criteria (3 listed)
- Age <18
- Specific indications for ETBD are documented
- ETBD with AERA device attempted-
Key exclusion criteria (2 listed)
- ETBD with device other than AERA®
- Previous ETBD procedure-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Tympanogram assessed by ear
Time frame: 27 months
Pure tone audiometry (PTA) assessed by ear
Time frame: 27 months
Valsalva maneuver assessed by ear
Time frame: 27 months
Inflammation score assessed by ear
Time frame: 27 months
Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient
Time frame: 27 months
Otitis Media- 6 Questionnaire (OM-6) assessed by patient
Time frame: 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Schutt, MD study director
Acclarent, an Integra LifeSciences Company
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysfunction of Eustachian Tube, run by Integra LifeSciences Corporation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Ellis (17817248422, ashley.ellis@integralife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free after ETBD with the AERA® device. (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.