Diagnostic Utility of Otosight Middle Ear Scope

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Otitis Media; Middle Ear Infection; Ear Infection
• Intervention / Treatment: Device: The OtoSight Middle Ear Scope

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 Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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 who have no history of ear tube placement.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Otosight, Otoscope, and Tympanogram; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Detection of middle ear fluid	Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools.	6 months
Categorization of middle ear fluid	Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Anna Messner, MD, Baylor College of Medicine; Study Chair: Yi-Chun Liu, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): June 29, 2023
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Otoscope; Tympanogram
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Otorhinolaryngologic Diseases; Ear Diseases; Infections; Communicable Diseases; Otitis; Otitis Media
• Other Study ID Numbers: H-52641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No one besides the PI, the study staff, the IRB and the sponsor will have access to identifiable research data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes