Otitis Media EffusionNCT07899177
Balloon Dilation of Eustachian Tube Versus Tympanostomy Tube in Management of Pediatric Obstructive Eustachian Tube Dysfunction
A study testing eustachian tube dilatation and tympanostomy tube insertion in people with Otitis Media Effusion, run by Mansoura University at 1 site in Egypt.
Trial summary
The study was conducted in children with otitis media with effusionto compare the efficacy and outcome of Balloon dilation of Eustachian tube versus tympanostomy tube . Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Otitis Media Effusion
- What is being tested?
- eustachian tube dilatation and tympanostomy tube insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who have OME with persistent symptoms (≥6 months) that failed to improve despite optimal medical treatment.
- Age 4-18 years (of both sexes).
Who cannot join
- Patulous ETD.
- Atelectatic/adhesive OM.
- History of drainage tube insertion or current tube insertion, prior Eustachian tube surgery, previous ME and mastoid surgery.
- Cleft palate or craniofacial syndrome; and prior radiation to the head and neck.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Balloon Dilation of Eustachian Tube Versus Tympanostomy Tube in Management of Pediatric Obstructive Eustachian Tube Dysfunction: a Randomized Controlled Trial.
The study was conducted in children with otitis media with effusionto compare the efficacy and outcome of Balloon dilation of Eustachian tube versus tympanostomy tube .
- Conditions
- Otitis Media Effusion
- Being tested
- eustachian tube dilatation, tympanostomy tube insertion
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eustachian tube dilatationProcedure or surgery
trans nasal endoscopic eustachian tube dilation
tympanostomy tube insertionProcedure or surgery
tympanostomy tube insertion in tympanic membrane
| Study group | Role | What they receive |
|---|---|---|
| Eustachian tube dilatation | Active comparator | Not described Receives: Procedure: eustachian tube dilatation |
| tympanostomy tube | Active comparator | Not described Receives: Procedure: tympanostomy tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Hearing and middle ear pressure improvement Pediatric eustachian tube dysfunction questionnaire
Hearing assessment by pure tone audiometry middle ear pressure assessment by tympanogram , toynbee and valsalva maneuvers And Pediatric eustachian tube dysfunction questionnaire
Measured: 3 months , 6 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start15 Jul 2025
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Otitis Media EffusionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hamdy Salem, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899177
- Sponsor's protocol ID
- MS.25.07.3237.R1
- Status last verified
- Jul 2025
- First submitted
- 17 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poe D, Anand V, Dean M, Roberts WH, Stolovitzky JP, Hoffmann K, Nachlas NE, Light JP, Widick MH, Sugrue JP, Elliott CL, Rosenberg SI, Guillory P, Brown N, Syms CA 3rd, Hilton CW, McElveen JT Jr, Singh A, Weiss RL Jr, Arriaga MA, Leopold JP. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. 2018 May;128(5):1200-1206. doi: 10.1002/lary.26827. Epub 2017 Sep 20.
PubMed 28940574McCoul ED, Anand VK. Eustachian tube balloon dilation surgery. Int Forum Allergy Rhinol. 2012 May-Jun;2(3):191-8. doi: 10.1002/alr.21007. Epub 2012 Jan 17.
PubMed 22253073Aboueisha MA, Attia AS, McCoul ED, Carter J. Efficacy and safety of balloon dilation of eustachian tube in children: Systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. 2022 Mar;154:111048. doi: 10.1016/j.ijporl.2022.111048. Epub 2022 Jan 21.
PubMed 35085875
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Balloon Dilation of Eustachian Tube Versus Tympanostomy Tube in Management of Pediatric Obstructive Eustachian Tube Dysfunction: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07899177
- Acronym / sponsor ID
- MS.25.07.3237.R1
- Conditions
- Otitis Media Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 27 Oct 2026 (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.
The study was conducted in children with otitis media with effusionto compare the efficacy and outcome of Balloon dilation of Eustachian tube versus tympanostomy tube .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eustachian tube dilatation | Active comparator | Procedure: eustachian tube dilatation |
| tympanostomy tube | Active comparator | Procedure: tympanostomy tube insertion |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients who have OME with persistent symptoms (≥6 months) that failed to improve despite optimal medical treatment.
- Age 4-18 years (of both sexes).
Key exclusion criteria (4 listed)
- Patulous ETD.
- Atelectatic/adhesive OM.
- History of drainage tube insertion or current tube insertion, prior Eustachian tube surgery, previous ME and mastoid surgery.
- Cleft palate or craniofacial syndrome; and prior radiation to the head and neck.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eustachian tube dilatationtrans nasal endoscopic eustachian tube dilation | Procedure or surgery | Eustachian tube dilatation |
| tympanostomy tube insertiontympanostomy tube insertion in tympanic membrane | Procedure or surgery | tympanostomy tube |
Primary outcome
Assessment of Hearing and middle ear pressure improvement Pediatric eustachian tube dysfunction questionnaire
Time frame: 3 months , 6 months interval
Hearing assessment by pure tone audiometry middle ear pressure assessment by tympanogram , toynbee and valsalva maneuvers And Pediatric eustachian tube dysfunction questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 28940574Poe D, Anand V, Dean M, Roberts WH, Stolovitzky JP, Hoffmann K, Nachlas NE, Light JP, Widick MH, Sugrue JP, Elliott CL, Rosenberg SI, Guillory P, Brown N, Syms CA 3rd, Hilton CW, McElveen JT Jr, Singh A, Weiss RL Jr, Arriaga MA, Leopold JP. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. 2018 May;128(5):1200-1206. doi: 10.1002/lary.26827. Epub 2017 Sep 20.
- Background: PubMed 22253073McCoul ED, Anand VK. Eustachian tube balloon dilation surgery. Int Forum Allergy Rhinol. 2012 May-Jun;2(3):191-8. doi: 10.1002/alr.21007. Epub 2012 Jan 17.
- Background: PubMed 35085875Aboueisha MA, Attia AS, McCoul ED, Carter J. Efficacy and safety of balloon dilation of eustachian tube in children: Systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. 2022 Mar;154:111048. doi: 10.1016/j.ijporl.2022.111048. Epub 2022 Jan 21.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eustachian tube dilatation and tympanostomy tube insertion in people with Otitis Media Effusion, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Hearing and middle ear pressure improvement Pediatric eustachian tube dysfunction questionnaire (time frame: 3 months , 6 months interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07899177, which also lists 3 linked publications.
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 27 Oct 2026.