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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DC022815-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| The Cleveland Clinic | OTHER |
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The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are:
-Accuracy and usability of doctors using laser otoscopes
Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational cohort | Pediatric patients 6 months to 18 years who have been scheduled for tympanostomy and ear tube placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser otoscope examination | Device | Patients will have short videos taken of their tympanic membranes under white light and laser illumination. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence | The primary endpoint is the accuracy, PPV, and NPV of the MEEscope in detecting MEE validated by myringotomy findings. These values will be compared to the standard white-light otoscopy findings in the same patients to demonstrate the relative accuracy of the experimental illumination vs white light illumination in detection of MEE. | From enrollment to data collection at tympanostomy typically at 2-3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients ages 6 months to 18 years who are scheduled to undergo unilateral or bilateral myringotomy with ear tube placement (tympanostomy) as part of their standard clinical care. Eligible participants will be identified prior to surgery based on clinical scheduling and medical history.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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