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Procedure
Posterior Tympanostomy Tube Left for Ear Infection
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months±30 days following tympanostomy tube placement
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months±30 days following tympanostomy tube placement
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months±30 days following tympanostomy tube placement
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perforation
Secondary outcome measures
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 moreOther outcome measures
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 moreTrial 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
555 Total Patients Enrolled
David H Chi, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
340 Total Patients Enrolled
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