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

Sponsor
Chiang Mai University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05813119
Collaborator
(none)
56
Enrollment
1
Location
10.9
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    56 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.
    Actual Study Start Date :
    Jul 1, 2022
    Actual Primary Completion Date :
    Jan 31, 2023
    Anticipated Study Completion Date :
    May 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology [6 months]

      agreement percentage

    2. efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology [6 months]

      Cohen's kappa coefficient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum Chiang Mai Thailand 50200

    Sponsors and Collaborators

    • Chiang Mai University

    Investigators

    • Principal Investigator: Suwicha K Isaradisaikul, MD, Department of Otolaryngology , Faculty of Medicine, Chiang Mai University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suwicha Isaradisaikul Kaewsiri, Principal Investigator, Chiang Mai University
    ClinicalTrials.gov Identifier:
    NCT05813119
    Other Study ID Numbers:
    • ENT-2564-08562
    First Posted:
    Apr 14, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Suwicha Isaradisaikul Kaewsiri, Principal Investigator, Chiang Mai University
    Middle Ear Disease
    otoscope
    Diagnosis
    Additional relevant MeSH terms:
    Ear Diseases
    Disease

    Study Results

    No Results Posted as of Apr 18, 2023