An observational study in Ear Infection, Middle Ear Infection and Otitis Media, sponsored by Baylor College of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 6 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Baylor College of Medicine · Observational
Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.
The purpose of this study is to compare the successful exam completion rate, the detection of middle ear fluid (versus no fluid), and the categorization of middle ear fluid (purulent vs. serous vs mucoid,) of routine otoscopy examination versus otosight examination versus tympanogram.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's enrollment of 165 is close to the median of 150 across 57 observational studies indexed under Otitis Media.
Browse Otitis Media studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Compared within Otitis Media, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Otitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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 who have no history of ear tube placement.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Prospective study using a convenience sample. There will be no group assignment or randomization. There is no intervention planned and therefore, no placebo group or use of controls.
Device: The OtoSight Middle Ear Scope
The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.
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.
Time frame: 6 months
Detection of middle ear fluid
Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools.
Time frame: 6 months
Categorization of middle ear fluid
Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools.
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: No — No one besides the PI, the study staff, the IRB and the sponsor will have access to identifiable research data.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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