Spectroscopic Evaluation of Middle Ear Infection (Withdrawn)

Middle Ear Infection Clinical Trial

Official title:

Spectroscopic Evaluation of Middle Ear Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01485471
• Other study ID #: 20108015
• Status: Withdrawn
• Start date: June 2011
• Est. completion date: June 2015

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Middle Ear Infection
• Otitis
• Otitis Media

Intervention

Device:
• Diffuse optical spectroscopy imaging
ear exam imaging

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Middle Ear exam	Diffuse optical spectroscopy imaging to evaluate ear drum	6 hours