Spectroscopic Evaluation of Middle Ear Infection (Withdrawn)

NCT01485471 | Withdrawn

• 1 other identifier: 20108015
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Middle Ear Infection

Keywords

Middle Ear Infection

Outcome Measures

Primary Outcomes (1)

• Middle Ear exam

  Diffuse optical spectroscopy imaging to evaluate ear drum

  6 hours

Study Arms (1)

Medical Tool

Diffuse optical spectroscopy imaging ear exam

Device: Diffuse optical spectroscopy imaging

Interventions

Diffuse optical spectroscopy imaging DEVICE

ear exam imaging

Medical Tool

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UCI otolaryngology clinic

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Elliot Botvinick, Ph.D

  Beckman Laser Institute

  PRINCIPAL INVESTIGATOR

• Bruce Tromberg, PhD

  Beckman Laser Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elliot Botvinick, Ph.D., Assistant Professor, Biomedical Engineering

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: December 5, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 1, 2022

Record last verified: 2022-10