NCT05641285

Diagnostic Utility of Otosight Middle Ear Scope

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 165 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ear Infection
• Middle Ear Infection
• Otitis Media

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-21
• Primary completion: 2023-06-29
• Completion: 2025-06-30
• First posted: 2022-12-07
• Last updated: 2024-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study