Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology

Completed

• Conditions: Diagnosis; Middle Ear Disease

• Registration Number: NCT05813119
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-31
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Study First Submitted QC: 2023-04-01
• Study First Posted: 2023-04-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology	6 months	Cohen's kappa coefficient

Trial Locations

Locations (1)

Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum; 🇹🇭 Chiang Mai, Thailand