Diagnostic Utility of Otosight Middle Ear Scope

N/AActive Not RecruitingNCT05641285

Baylor College of Medicine165 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

165

Conditions

Ear Infection Middle Ear Infection Otitis Media

Interventions

The OtoSight Middle Ear ScopeDEVICE

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Texas Children's Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.