Spectroscopic Evaluation of Middle Ear Infection

This study has been withdrawn prior to enrollment.
(No paticipants enrolled)
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01485471
First received: August 2, 2011
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention
Middle Ear Infection
Device: Diffuse optical spectroscopy imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Spectroscopic Evaluation of Middle Ear Infection

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Middle Ear exam [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Diffuse optical spectroscopy imaging to evaluate ear drum


Enrollment: 0
Study Start Date: June 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Medical Tool
Diffuse optical spectroscopy imaging ear exam
Device: Diffuse optical spectroscopy imaging
ear exam imaging
Other Name: Diffuse Optical Spectroscopy Imaging

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

UCI otolaryngology clinic

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant woman
  2. Incompetent adults (i.e. individuals with cognitive impairment)
  3. No diagnose of middle ear infection and no plan for surgery procedure.
  4. Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01485471

Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Elliot Botvinick, Ph.D Beckman Laser Institute
Study Director: Bruce Tromberg, PhD Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, Elliot Botvinick, Ph.D., Assistant Professor, Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01485471     History of Changes
Other Study ID Numbers: NIH-LAMMP-2010-8015
Study First Received: August 2, 2011
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Middle Ear Infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 30, 2015