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NCT05641285 Clinical Trial

Diagnostic Utility of Otosight Middle Ear Scope

Otitis Media Clinical Trial

Official title:
Diagnostic Utility of the Otosight Middle Ear Scope in Acute Otitis Media

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05641285
Other study ID # H-52641
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 21, 2023
Est. completion date December 30, 2024

Study information
Verified date July 2023
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.

Description:

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Texas Children's Hospital Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome
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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