Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT04812093
Status:
RECRUITING
Last Update Posted:
2025-01-15
First Post:
2021-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spectroscopic Evaluation of Middle Ear Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Middle Ear Exam', 'timeFrame': '5 minutes', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Middle Ear Infection'], 'conditions': ['Middle Ear Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'UCI otolaryngology clinic, CHOC, and La Veta', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male/ female at all age- newborn to adult.\n2. Non- pregnant woman.\n3. Diagnose of middle ear infection and plan for surgery procedure.\n\nExclusion Criteria:\n\n1. Pregnant woman\n2. Incompetent adults (i.e. individuals with cognitive impairment)\n3. No diagnose of middle ear infection and no plan for surgery procedure.\n4. Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04812093', 'briefTitle': 'Spectroscopic Evaluation of Middle Ear Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Spectroscopic Evaluation of Middle Ear Infection', 'orgStudyIdInfo': {'id': '20163039'}, 'secondaryIdInfos': [{'id': 'R43DC018248', 'link': 'https://reporter.nih.gov/quickSearch/R43DC018248', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical Tool', 'description': 'Spectroscopic otoscope', 'interventionNames': ['Device: Spectroscopic otoscope measurements']}], 'interventions': [{'name': 'Spectroscopic otoscope measurements', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Medical Tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gurpreet Ahuja, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Orange County (CHOC)", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hamid Djalilian, MD', 'role': 'CONTACT'}], 'facility': 'UCI Otolaryngology Clinic', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'John Weidling, PhD', 'role': 'CONTACT', 'email': 'jweidlin@uci.edu', 'phone': '949-824-9613'}], 'overallOfficials': [{'name': 'Elliot Botvinick', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calfornia Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Biomedical Engineering and Surgery', 'investigatorFullName': 'Elliot L Botvinick', 'investigatorAffiliation': 'University of California, Irvine'}}}}