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OpenTrials
Active, Not Recruiting

NCT Number: NCT05641285

Diagnostic Utility of Otosight Middle Ear Scope

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ear Infection Ear Diseases Middle Ear Infection Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The OtoSight Middle Ear Scope

Device

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.

Primary outcomes

  1. Exam Completion Rate

    Time frame: 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.

  2. Detection of middle ear fluid

    Time frame: 6 months

    Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools.

  3. Categorization of middle ear fluid

    Time frame: 6 months

    Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools.

Secondary outcomes

  1. Timed Evaluation of Clinic Flow

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Dec 7, 2022
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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