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Diagnostic Utility of Otosight Middle Ear Scope

NCT05641285 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 165

Last updated 2024-10-31

No results posted yet for this study

Summary

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

Conditions

  • Ear Infection
  • Middle Ear Infection
  • Otitis Media

Interventions

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Anna Messner, MD · Baylor College of Medicine

  • Yi-Chun Liu, MD · Baylor College of Medicine

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2023-06-29
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641285 on ClinicalTrials.gov