Diagnostic Utility of Otosight Middle Ear Scope

NCT05641285 | Active Not Recruiting FDA Device

• 1 other identifier: H-52641
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ear Infection; Middle Ear Infection; Otitis Media

Keywords

Otoscope; Tympanogram

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Timed Evaluation of Clinic Flow

  6 months

Study Arms (1)

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

Interventions

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.

Otosight, Otoscope, and Tympanogram

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who have a history of ear tube placement

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Otitis; Otitis Media

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Anna Messner, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Yi-Chun Liu, MD

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 7, 2022
• Study Start: February 21, 2023
• Primary Completion: June 29, 2023
• Study Completion: June 30, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)