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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 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.

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

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

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 more

Other 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 more

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).

0 / 4Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 40 and above eligible to participate in this medical study?

"To be eligible for this clinical trial, applicants must fall within the age range of 6 months to 14 years. Among all the ongoing studies associated with this trial, there are a total of 20 studies focused on patients under the age of 18 and an additional 5 studies targeting individuals over the age of 65."

Answered by AI

What are the specific criteria for individuals to qualify and participate in this trial?

"To be eligible for participation in this clinical trial, patients must have a diagnosed ear infection and fall within the age range of 6 months to 14 years. The study aims to recruit a total of 386 individuals."

Answered by AI

Is this medical study currently open for enrollment?

"Apologies for the confusion. As per the current information available on clinicaltrials.gov, this particular trial is not currently seeking participants. The initial posting date was January 1st, 2024, and it was last updated on January 3rd, 2024. However, there are indeed 22 other trials actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Posterior vs. Anterior Tympanostomy Tube Placement

David Chi, MD 2024. "Posterior vs. Anterior Tympanostomy Tube Placement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191562.

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