ClinicalTrials.gov
ClinicalTrials.gov Menu

Spectroscopic Evaluation of Middle Ear Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01485471
Recruitment Status : Withdrawn (No paticipants enrolled)
First Posted : December 5, 2011
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

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.

Condition or disease Intervention/treatment
Middle Ear Infection Device: 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


Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Spectroscopic Evaluation of Middle Ear Infection
Study Start Date : June 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Group/Cohort Intervention/treatment
Medical Tool
Diffuse optical spectroscopy imaging ear exam
Device: Diffuse optical spectroscopy imaging
ear exam imaging



Primary Outcome Measures :
  1. Middle Ear exam [ Time Frame: 6 hours ]
    Diffuse optical spectroscopy imaging to evaluate ear drum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Middle Ear Infection

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