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Clinical Trials/NCT05813119
NCT05813119
Completed
N/A

Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.

Chiang Mai University1 site in 1 country56 target enrollmentJuly 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Middle Ear Disease
Sponsor
Chiang Mai University
Enrollment
56
Locations
1
Primary Endpoint
efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

For diagnosis of external and middle ear diseases, an otoscope is a key instrument to use. A microscope has been used as a reference standard to confirm pathology. An endoscope has been also widely used. Both microscope and endoscope provide an excellent image quality, can record and capture the images, and the images can be visualized with an export system.

A digital otoscope is widely available and more affordable. A comparative study of the efficacy of the endoscope and the digital endoscope will be performed.

Detailed Description

A comparative study for the diagnosis of middle ear disease usingTeslong digital otoscope, model MS450D39, and the otoendoscope will be performed. The participants will be recruited at the ENT clinic, University Hospital. A handheld otoscope will be used to identify the patients who have the pathology of the middle ear. The images will be captured with both endoscopes and will be reviewed by staff, residents training in ENT, and residents training in ENT and family medicine.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
January 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suwicha Isaradisaikul Kaewsiri

Principal Investigator

Chiang Mai University

Eligibility Criteria

Inclusion Criteria

  • Patients who were diagnosed with middle ear disease after examination by conventional otoscope at ENT clinic, Chiang Mai University Hospital
  • Had otoscopic examination with both digital otoscope and otoendoscope in the same visit in one ear or both ears

Exclusion Criteria

  • Having abnormal external ear canals such as external auditory canal stenosis, otitis external, otomycosis, or pus/ debris in the ear canal that obscures the view of the eardrum
  • Changing the pathology of the ear canal or middle ear in the same visit
  • Trauma after otoscopic examination
  • can not record or focus the entire view of the eardrum by both otoscopes

Outcomes

Primary Outcomes

efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology

Time Frame: 6 months

Cohen's kappa coefficient

Study Sites (1)

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