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CompletedNCT05813119otoscopyUpdated Aug 30, 2023

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

An observational study in Middle Ear Disease and Diagnosis, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-30.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Chiang Mai University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
56
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Middle Ear Disease
  • Diagnosis

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Keywords

  • Middle Ear Disease
  • otoscope
  • Diagnosis
03

In context

Lead sponsor

Chiang Mai University is the lead sponsor of 119 studies on the registry; 12 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who visit at ENT clinic, Chiang Mai University Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
56 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    agreement percentage

    Time frame: 6 months

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

    Cohen's kappa coefficient

    Time frame: 6 months

07

Study locations

1 site
  • Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum
    Chiang Mai, 50200, Thailand
08

References and documents

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. PubMed 26156976 ↗
  • 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. PubMed 28118550 ↗
  • 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. PubMed 31565683 ↗
  • 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. PubMed 29544905 ↗
  • 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. PubMed 30463434 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Jan 2023, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2022
First posted
Apr 14, 2023
StartActual
Jul 1, 2022
Primary completionActual
Jan 31, 2023
CompletionActual
Jan 31, 2023
Last update
Aug 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05813119
Lead sponsor
Chiang Mai University
Responsible party
Suwicha Isaradisaikul Kaewsiri (Principal Investigator, Chiang Mai University) — Principal investigator
First posted
Apr 14, 2023
Start date
Jul 1, 2022
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023
Last update
Aug 30, 2023

Study contacts

Suwicha K Isaradisaikul, MD
principal investigator · Department of Otolaryngology , Faculty of Medicine, Chiang Mai University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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