Diagnostic Utility of Otosight Middle Ear Scope

NCT ID: NCT05641285

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-21

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Ear Infection Middle Ear Infection Otitis Media

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

The OtoSight Middle Ear Scope

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Anna Messner

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Messner, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Yi-Chun Liu, MD

Role: STUDY_CHAIR

Baylor College of Medicine

Locations

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Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-52641

Identifier Type: -

Identifier Source: org_study_id

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