- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812093
Spectroscopic Evaluation of Middle Ear Infection
February 2, 2024 updated by: Elliot L Botvinick, University of California, Irvine
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The research can use low energy LED signal light sent into the ear canal to measure the tissue optical properties including the absorption of the light signal and the amount of signal that will be backscattered by the tissue components.
These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: John Weidling, PhD
- Phone Number: 949-824-9613
- Email: jweidlin@uci.edu
Study Locations
-
-
California
-
Orange, California, United States, 92868
- Recruiting
- Children's Hospital of Orange County (CHOC)
-
Contact:
- Gurpreet Ahuja, MD
-
Orange, California, United States, 92868
- Recruiting
- UCI Otolaryngology Clinic
-
Contact:
- Hamid Djalilian, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 21 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
UCI otolaryngology clinic, CHOC, and La Veta
Description
Inclusion Criteria:
- Male/ female at all age- newborn to adult.
- Non- pregnant woman.
- Diagnose of middle ear infection and plan for surgery procedure.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Medical Tool
Spectroscopic otoscope
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Middle Ear Exam
Time Frame: 5 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elliot Botvinick, University of Calfornia Irvine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 26, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 19, 2021
First Submitted That Met QC Criteria
March 19, 2021
First Posted (Actual)
March 23, 2021
Study Record Updates
Last Update Posted (Estimated)
February 6, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20163039
- R43DC018248 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Northwell HealthCompletedMiddle Ear Disease | Pressure Injury | Eustachian Tube Dysfunction | Ear Barotrauma | Middle Ear; Injury | Middle Ear BarotraumaUnited States
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-
St. Justine's HospitalCompleted
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Ziv HospitalCompletedParental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room
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Kahramanmaras Sutcu Imam UniversityCompletedCerebral Palsy | Infant, Premature, Diseases | Neurologic Disorder | Infant, Newborn, Disease | Infant Development | Development Delay | Infant, Very Low Birth Weight | Infant, Small for Gestational Age | Infant AsphyxiaTurkey