Study Results
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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ACTIVE_NOT_RECRUITING
165 participants
OBSERVATIONAL
2023-02-21
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
12 Years
ALL
Yes
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Anna Messner
Professor
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
Countries
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Other Identifiers
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H-52641
Identifier Type: -
Identifier Source: org_study_id
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