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Clinical Trials/NCT04812093
NCT04812093
Recruiting
Not Applicable

Spectroscopic Evaluation of Middle Ear Infection

University of California, Irvine2 sites in 1 country150 target enrollmentFebruary 26, 2021

Overview

Phase
Not Applicable
Intervention
Spectroscopic otoscope measurements
Conditions
Middle Ear Infection
Sponsor
University of California, Irvine
Enrollment
150
Locations
2
Primary Endpoint
Middle Ear Exam
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researchers can use LED-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.

Detailed Description

The research can use low energy LED signal light sent into the ear canal to measure the tissue optical properties including the absorption of the light signal and the amount of signal that will be backscattered by the tissue components. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Registry
clinicaltrials.gov
Start Date
February 26, 2021
End Date
December 31, 2028
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elliot L Botvinick

Professor of Biomedical Engineering and Surgery

University of California, Irvine

Eligibility Criteria

Inclusion Criteria

  • Male/ female at all age- newborn to adult.
  • Non- pregnant woman.
  • Diagnose of middle ear infection and plan for surgery procedure.

Exclusion Criteria

  • Pregnant woman
  • Incompetent adults (i.e. individuals with cognitive impairment)
  • No diagnose of middle ear infection and no plan for surgery procedure.
  • Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.

Arms & Interventions

Medical Tool

Spectroscopic otoscope

Intervention: Spectroscopic otoscope measurements

Outcomes

Primary Outcomes

Middle Ear Exam

Time Frame: 5 minutes

The level of light scattering and absorption as measured will be the predictor and presence of fluid behind the ear drum as determined by the surgeon during ear tube placement procedure will be our outcome variable.

Study Sites (2)

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