Spectroscopic Evaluation of Middle Ear Infection
2 other identifiers
observational
150
1 country
2
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. Researchers can use LED-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2021
CompletedFirst Submitted
Initial submission to the registry
March 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 13, 2026
January 1, 2026
7.8 years
March 19, 2021
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Middle Ear Exam
The level of light scattering and absorption as measured will be the predictor and presence of fluid behind the ear drum as determined by the surgeon during ear tube placement procedure will be our outcome variable.
5 minutes
Study Arms (1)
Medical Tool
Spectroscopic otoscope
Interventions
Spectroscopic otoscope measurements are taken with the investigational device. Each measurement consists of placing the device in the ear canal and illuminating the ear with multiple light sources in a short period of time. If wax is present in the ear canal, it is removed by the study physician and another measurement is taken.
Eligibility Criteria
UCI otolaryngology clinic, CHOC, and La Veta
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Hospital of Orange County (CHOC)
Orange, California, 92868, United States
UCI Otolaryngology Clinic
Orange, California, 92868, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elliot Botvinick
University of Calfornia Irvine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Biomedical Engineering and Surgery
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 23, 2021
Study Start
February 26, 2021
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share