Diagnostic Utility of Otosight Middle Ear Scope

Sponsor

Baylor College of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05641285

Collaborator

(none)

125

Enrollment

5.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ear Infection Middle Ear Infection Otitis Media	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 Design

Study Type:

Observational

Anticipated Enrollment :

125 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator: Anna Messner, MD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Messner, Professor, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT05641285

Other Study ID Numbers:

H-52641

First Posted:

Dec 7, 2022

Last Update Posted:

Jan 4, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Anna Messner, Professor, Baylor College of Medicine

Otoscope

Tympanogram

Additional relevant MeSH terms:

Infections

Communicable Diseases

Otitis

Otitis Media

Study Results

No Results Posted as of Jan 4, 2023