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Clinical Trials/NCT01485471
NCT01485471
Withdrawn
Not Applicable

Spectroscopic Evaluation of Middle Ear Infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Middle Ear Infection
Sponsor
University of California, Irvine
Primary Endpoint
Middle Ear exam
Status
Withdrawn
Last Updated
3 years 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. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for the analysis of ear drum and the middle ear.

Detailed Description

The research can use low energy laser signal light from Diffuse optical spectroscopy that is harmless to the tissues and sends them into the ear canal to measure the tissue optical properties including the absorption of the laser signal and the amount of signal that will be backscattered by the ear drum. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum. Diffuse optical spectroscopy an imaging method use near- infrared light to measure absolute tissue concentrations of oxyhemoglobin, deoxyhemoglobin, water, and lipids, as well as subtle changes in water and protein binding states

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
June 2015
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Beckman Laser Institute and Medical Center

Elliot Botvinick, Ph.D., Assistant Professor, Biomedical Engineering

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.

Outcomes

Primary Outcomes

Middle Ear exam

Time Frame: 6 hours

Diffuse optical spectroscopy imaging to evaluate ear drum

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