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NCT06191562 · ClinicalTrials.gov registry record · NA
Posterior vs. Anterior Tympanostomy Tube Placement
A NA study of Otitis Media in Children and Chronic Otitis Media With Effusion, sponsored by David Chi, MD.
- Active
- Registry status
- NA
- Development phase
- 386
- Enrollment target
- 2
- Study locations
NCT06191562: Active NA study of Otitis Media in Children and Chronic Otitis Media With Effusion, sponsored by David Chi, MD.
NCT06191562 is a NA study of Otitis Media in Children and Chronic Otitis Media With Effusion that is active but no longer recruiting, run by David Chi, MD. The registered enrollment target is 386 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06191562, a NA study of Otitis Media in Children and Chronic Otitis Media With Effusion, is active but no longer recruiting, sponsored by David Chi, MD.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 386 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tubes usually fall out of the ear drum on their own. In most patients, the hole in the ear drum where the tube used to be closes on its own. Sometimes (in about 2% of patients), the hole does not close on its own and might need surgery. We want to study ear tube placement in the posterior-inferior quadrant because surgery to repair a hole in the eardrum is easier in this location. For this study, children will receive an ear tube in the usual location (anterior-inferior quadrant) in one ear and the new location (posterior-inferior quadrant) in the other ear. Researchers will determine which ear has the new location using random assignment (like flipping a coin). Researchers will collect information about hearing tests, whether there is ear drainage (otorrhea), if the tube is blocked (occluded), and how the ear drum looks for up to 37 months after tube placement. Participants will answer study questions at 2-12 weeks and 6, 12, 18, 24, 30, and 36 months after surgery. These questions will ask about whether tubes have fallen out of the ear drum, whether there is a hole in the ear drum, whether there has been drainage from the ear or other ear symptoms, and whether there have been any visits to the doctor for ear problems. Researchers will use this information to compare ears with anterior-inferior tube placement and ears with posterior-inferior tube placement to see if there are differences in common complications following tube placement.
Primary Outcome
Percentage of ears with persistent (\>3 month) perforation of the tympanic membrane
Conditions Studied
Interventions
- DEVICE Tympanostomy tube
Study Locations (2)
Pennsylvania
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
- UPMC Children's Hospital of Pittsburgh North - Sewickley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2024-02-29 |
| Est. Completion | 2028-02 |
| Phase | NA |
What the registry record for NCT06191562 still lists
NCT06191562 is an interventional study that assigns participants to a tested intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Otitis Media in Children appearing as the primary indexed condition, and to 1 intervention - of which Tympanostomy tube is the first listed.
NCT06191562 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06191562 about?
NCT06191562 is a clinical study titled "Posterior vs. Anterior Tympanostomy Tube Placement". The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. Howev...
What is the current status of trial NCT06191562?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 386 participants. The study started on 2024-02-29. Estimated completion is 2028-02.
What conditions does trial NCT06191562 study?
This clinical trial studies the following conditions: Otitis Media in Children, Chronic Otitis Media With Effusion, Recurrent Acute Otitis Media.
What interventions are being tested in trial NCT06191562?
The interventions under investigation include: Tympanostomy tube (DEVICE).
Who is sponsoring clinical trial NCT06191562?
This trial is sponsored by David Chi, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06191562 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06191562's enrollment target sits among peer trials
386 271st of 2000 higher than 1,730 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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