Skip to main content
OpenTrials
Completed

NCT Number: NCT05813119

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Middle Ear Disease Diagnosis Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum

Chiang Mai, 50200, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

    agreement percentage

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

    Time frame: 6 months

    Cohen's kappa coefficient

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Acronym: otoscopy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.