New ear tube position may reduce surgery risks for kids
NCT ID NCT06191562
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at where ear tubes are placed in children with ear infections. Normally, tubes go in the front part of the eardrum, but this trial places them in the back part in one ear to see if it lowers the risk of a hole that won't heal. About 386 children will be followed for up to 3 years to compare complications like drainage, blockage, and persistent holes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tympanostomy tube (ear tube)
- What this could lead to
- If successful, this could show that placing ear tubes in a different spot on the eardrum reduces the chance of a hole that won't close, making future repairs easier.
- What could go wrong
- This is a small, early-stage study comparing two surgical techniques, not testing a new drug. The benefit may be small, and results may not apply to all children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 386 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 14 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ages 6 months -14 years 2. Bilateral tympanostomy tube placement 3. First tympanostomy tubes placement 4. Indication for tympanostomy tube placement is otitis media Exclusion Criteria: 1. Undergoing tympanostomy tube placement for indication other than otitis media 2. Receiving tubes other than Armstrong grommet. 3. Genetic disorder that impacts the craniofacial structure, immune system, or mucosal secretions such as Downs syndrome, Stickler syndrome, Treacher Collins syndrome, other genetic disorder associated with craniofacial anomalies, Severe Combined Immunodeficiency disorder, Cystic Fibrosis, or Primary Ciliary Dyskinesia 4. Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP) 5. Caregivers who cannot speak, read, or write in English proficiently 6. Prior or current otologic surgery other than tympanostomy tube placement 7. On systemic corticosteroids at the time of enrollment 8. Immunodeficiency (acquired or congenital) 9. Current retraction, cholesteatoma, or middle ear mass 10. Atresia 11. Sensorineural hearing loss 12. Known ossicular chain anomaly
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
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UPMC Children's Hospital of Pittsburgh North
Sewickley, Pennsylvania, 15143, United States
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