Spectroscopic Evaluation of Middle Ear Infection

This study has suspended participant recruitment.
(suspended by the IRB)
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01485471
First received: August 2, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

This study is to asses the middle ear space use optical diagnostic technology to diagnosis of middle ear infection. Diffuse optical spectroscopy (DOS) and diffuse optical imaging (DOI) are an imaging method developed at the UCI, Beckman Laser Institute.


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:
  • Optical imaging assess properties of the middle ear space [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    The DOS technology assess presence of middle ear fluid or ear drum inflammation during surgical procedure


Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diffuse optical spectroscopy imaging
Diffuse optical spectroscopy imaging ear exam
Device: Diffuse optical spectroscopy imaging
ear exam imaging
Other Name: DOSI

Detailed Description:

The research can use low energy laser signal light from DOS device shine into the ear canal to determine the properties of the ear such as the presence of fluid or inflammation of the eardrum.

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485471

Locations
United States, California
UCI Beckman Laser Institute
Irvine, California, United States, 92612
UCI otolaryngology clinic
Orange, California, United States, 92868
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: Elliot Botvinick, Ph.D UCI Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01485471     History of Changes
Other Study ID Numbers: LAMMP SMM30139
Study First Received: August 2, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 24, 2014