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CompletedNCT07899177Updated Oct 27, 2026

Balloon Dilation of Eustachian Tube Versus Tympanostomy Tube in Management of Pediatric Obstructive Eustachian Tube Dysfunction

An interventional study of eustachian tube dilatation and tympanostomy tube insertion in Otitis Media Effusion, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jul 2025, registered Oct 2026).
Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
4 Years to 18 Years
Sex
All
01

Study 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 .

02

Conditions studied

  • Otitis Media Effusion
03

In context

Otitis Media with Effusion

86 studies on the registry are indexed under Otitis Media with Effusion; 15 are open to participants now.

This study's enrollment of 44 is below the median of 80 across 60 interventional studies indexed under Otitis Media with Effusion.

Browse Otitis Media with Effusion studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Mansoura University studies →

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

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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. Patients who have OME with persistent symptoms (≥6 months) that failed to improve despite optimal medical treatment.
  2. Age 4-18 years (of both sexes).

Exclusion criteria

Exclusion Criteria:

  1. Patulous ETD.
  2. Atelectatic/adhesive OM.
  3. History of drainage tube insertion or current tube insertion, prior Eustachian tube surgery, previous ME and mastoid surgery.
  4. Cleft palate or craniofacial syndrome; and prior radiation to the head and neck.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    Eustachian tube dilatation

    Procedure: eustachian tube dilatation

  • Active comparator
    tympanostomy tube

    Procedure: tympanostomy tube insertion

Interventions

  • Procedureeustachian tube dilatation

    trans nasal endoscopic eustachian tube dilation

  • Proceduretympanostomy tube insertion

    tympanostomy tube insertion in tympanic membrane

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months , 6 months interval

07

Study locations

1 site
  • Mansoura Faculty of Medicine
    Al Mansurah, Egypt
08

References and documents

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 28940574 ↗
  • McCoul 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 22253073 ↗
  • Aboueisha 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 documents

  • Protocol and statistical analysis plan · Mar 3, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2025 to primary completion in Jul 2026, 12 months.

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

Registered
Oct 17, 2026
First posted
Oct 27, 2026
StartActual
Jul 15, 2025
Primary completionActual
Jul 15, 2026
CompletionActual
Jul 15, 2026
Last update
Oct 27, 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.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07899177
Lead sponsor
Mansoura University
Responsible party
Eman Hamdy Salem (prof., Mansoura University) — Principal investigator
First posted
Oct 27, 2026
Start date
Jul 15, 2025
Primary completion
Jul 15, 2026
Completion
Jul 15, 2026
Last update
Oct 27, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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