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Procedure

Tympanostomy Tube Placement for Ear Infections

N/A
Recruiting
Led By David H Chi, MD
Research Sponsored by David Chi, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 6 months -14 years
Bilateral tympanostomy tube placement
Must not have
On systemic corticosteroids at the time of enrollment
Immunodeficiency (acquired or congenital)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months±30 days following tympanostomy tube placement
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two different locations for placing ear tubes in the ear drum. Normally, ear tubes are placed in one part of the ear drum, but this study wants to see if placing them in

Who is the study for?
This trial is for children with chronic ear infections. They will receive tympanostomy tubes, commonly known as ear tubes, to help drain fluid and improve hearing. The study requires that one tube be placed in the usual front-lower part of the eardrum and another in the back-lower part.
What is being tested?
The study aims to see if placing an ear tube in a different part of the eardrum affects how often complications occur after surgery. Researchers will compare outcomes like healing time, drainage issues, blockages, and whether additional doctor visits are needed.
What are the potential side effects?
Possible side effects include persistent holes in the eardrum requiring surgery or discomfort from drainage or blockage of the tubes. Hearing tests and regular check-ups will monitor these conditions over a period up to 37 months.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 months and 14 years old.
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I have tubes in both ears.
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I am getting my first ear tubes.
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I need ear tubes because of middle ear infections.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking corticosteroids.
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I have a weakened immune system.
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I have a growth or abnormal skin in my middle ear.
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I have atresia.
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I have hearing loss that is not due to earwax or an ear infection.
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I have had ear surgery, but not for ear tubes.
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I am getting ear tubes placed for reasons other than middle ear infections.
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I have a genetic condition affecting my face, immune system, or mucosal secretions.
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I have a known abnormality in the bones of my middle ear.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months±30 days following tympanostomy tube placement
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months±30 days following tympanostomy tube placement for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Perforation
Secondary study objectives
Ability to see through lumen and assess tube patency at 2-12 weeks
Ability to see through lumen and assess tube patency at 6 months
Atrophy or retraction at tube site
+11 more
Other study objectives
Ability to see through lumen and assess tube patency at 12 months
Ability to see through lumen and assess tube patency at 18 months
Ability to see through lumen and assess tube patency at 24 months
+34 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Posterior Tympanostomy Tube RightExperimental Treatment1 Intervention
Patients in whom the right ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location).
Group II: Posterior Tympanostomy Tube LeftExperimental Treatment1 Intervention
Patients in whom the left ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location).

Find a Location

Who is running the clinical trial?

David Chi, MDLead Sponsor
3 Previous Clinical Trials
563 Total Patients Enrolled
David H Chi, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
341 Total Patients Enrolled
~257 spots leftby Feb 2028
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