- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05813119
Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology (otoscopy)
Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chiang Mai, Thailand, 50200
- Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology
Time Frame: 6 months
|
agreement percentage
|
6 months
|
efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology
Time Frame: 6 months
|
Cohen's kappa coefficient
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suwicha K Isaradisaikul, MD, Department of Otolaryngology , Faculty of Medicine, Chiang Mai University
Publications and helpful links
General Publications
- Rappaport KM, McCracken CC, Beniflah J, Little WK, Fletcher DA, Lam WA, Shane AL. Assessment of a Smartphone Otoscope Device for the Diagnosis and Management of Otitis Media. Clin Pediatr (Phila). 2016 Aug;55(9):800-10. doi: 10.1177/0009922815593909. Epub 2015 Jul 7. No abstract available.
- Moshtaghi O, Sahyouni R, Haidar YM, Huang M, Moshtaghi A, Ghavami Y, Lin HW, Djalilian HR. Smartphone-Enabled Otoscopy in Neurotology/Otology. Otolaryngol Head Neck Surg. 2017 Mar;156(3):554-558. doi: 10.1177/0194599816687740. Epub 2017 Jan 24.
- Bhavana K, Ahmad M, Sharma P. Smartphone Otoscopy Sans Attachment: A Paradigm Shift in Diagnosing Ear Pathologies. OTO Open. 2018 Jul 19;2(3):2473974X18786496. doi: 10.1177/2473974X18786496. eCollection 2018 Jul-Sep.
- Mousseau S, Lapointe A, Gravel J. Diagnosing acute otitis media using a smartphone otoscope; a randomized controlled trial. Am J Emerg Med. 2018 Oct;36(10):1796-1801. doi: 10.1016/j.ajem.2018.01.093. Epub 2018 Jan 31.
- Chan KN, Silverstein A, Bryan LN, McCracken CE, Little WK, Shane AL. Comparison of a Smartphone Otoscope and Conventional Otoscope in the Diagnosis and Management of Acute Otitis Media. Clin Pediatr (Phila). 2019 Mar;58(3):302-306. doi: 10.1177/0009922818812480. Epub 2018 Nov 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENT-2564-08562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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