Otitis Media Clinical Trial
Official title:
Diagnostic Utility of the Otosight Middle Ear Scope in Acute Otitis Media
Verified date | July 2023 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.
Status | Active, not recruiting |
Enrollment | 165 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 29, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 12 Years |
Eligibility | Inclusion Criteria: - Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses. Exclusion Criteria: - Patients who have a history of ear tube placement |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exam Completion Rate | Compare the successful exam completion rate of these three diagnostic tools.
For the Otosight device: presence or absence of visible tympanic membrane, and presence or absence of graph indicating fluid/no fluid in the middle ear. For tympanogram: presence or absence of interpretable tracing indicating normal tympanic membrane movement, retracted tympanic membrane, or no movement of tympanic membrane. For the Otoscope: success is visualization of the tympanic membrane versus unable to see tympanic membrane. |
6 months | |
Primary | Detection of middle ear fluid | Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools. | 6 months | |
Primary | Categorization of middle ear fluid | Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools. | 6 months | |
Secondary | Timed Evaluation of Clinic Flow | Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic by timing how long it takes for the MA and/or MD to complete the Otosight exam. | 6 months |
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