Diagnostic Utility of Otosight Middle Ear Scope

Baylor College of Medicine

Status: Active, not recruiting

Conditions: Middle Ear Infection; Ear Infection; Otitis Media

Treatments: Device: The OtoSight Middle Ear Scope

Study type: Observational

Funder types: Other

Identifiers

NCT05641285

H-52641

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

165 participants in 1 patient group

Otosight, Otoscope, and Tympanogram

Description:

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.

Treatment:

Device: The OtoSight Middle Ear Scope