Diagnostic Utility of Otosight Middle Ear Scope

Active, not recruiting

• Conditions: Otitis Media; Middle Ear Infection; Ear Infection
• Interventions: Device: The OtoSight Middle Ear Scope

• Registration Number: NCT05641285
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-07
• Study Start: 2023-02-21
• Primary Completion: 2023-06-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 165

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.

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Exclusion Criteria

• Patients who have a history of ear tube placement

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Otosight, Otoscope, and Tympanogram	The OtoSight Middle Ear Scope	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.

Primary Outcome Measures

Name	Time	Method
Detection of middle ear fluid	6 months	Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools.
Categorization of middle ear fluid	6 months	Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools.
Exam Completion Rate	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Timed Evaluation of Clinic Flow	6 months	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.

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States