Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT06944795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SWIR Otoscopy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010034', 'term': 'Otitis Media with Effusion'}, {'id': 'D010031', 'term': 'Otitis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The physician who performs the tympanostomy tube placement procedure will not be analyzing the SWIR otoscope images. A different physician and a computer program will analyze the images for presence or absence of fluid.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of accurate diagnoses made by SWIR otoscope as confirmed by presence/absence of fluid during tympanostomy tube placement', 'timeFrame': '30 minutes', 'description': "Patients who are having a tympanostomy tube placement procedure at the LPCH will undergo removal of middle ear fluid as part of their standard of care. During the procedure, the physician will use the SWIR otoscope to take images using the SWIR and the white light otoscope. The physician conducting the procedure will take note of whether there was a presence of absence of middle ear fluid. A different physician and a computer program. The accuracy of the otscopes will be determined by comparing the physician and program's diagnoses to physical presence of fluid when the ear is drained during the tympanostomy tube placement."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['middle ear infections', 'ear infections', 'pediatric ear infections', 'otitis media', 'chronic otitis media', 'chronic otitis media with effusion'], 'conditions': ['Otitis Media', 'Otitis Media Chronic', 'Otitis Media Effusion']}, 'referencesModule': {'references': [{'pmid': '6423968', 'type': 'BACKGROUND', 'citation': 'Martynkina LP, Vengerov IuIu, Bespalova IA, Sergeeva GI, Tikhonenko AS. [Structure of the interphase chromatin in the ciliata Bursaria truncatella macronucleus. II. Loop organization of inactive chromatin clumps]. Mol Biol (Mosk). 1984 Jan-Feb;18(1):272-6. Russian.'}, {'pmid': '34131163', 'type': 'BACKGROUND', 'citation': 'Kashani RG, Mlynczak MC, Zarabanda D, Solis-Pazmino P, Huland DM, Ahmad IN, Singh SP, Valdez TA. Shortwave infrared otoscopy for diagnosis of middle ear effusions: a machine-learning-based approach. Sci Rep. 2021 Jun 15;11(1):12509. doi: 10.1038/s41598-021-91736-9.'}, {'pmid': '12456901', 'type': 'BACKGROUND', 'citation': 'Pichichero ME. Diagnostic accuracy, tympanocentesis training performance, and antibiotic selection by pediatric residents in management of otitis media. Pediatrics. 2002 Dec;110(6):1064-70. doi: 10.1542/peds.110.6.1064.'}, {'pmid': '11576009', 'type': 'BACKGROUND', 'citation': 'Pichichero ME, Poole MD. Assessing diagnostic accuracy and tympanocentesis skills in the management of otitis media. Arch Pediatr Adolesc Med. 2001 Oct;155(10):1137-42. doi: 10.1001/archpedi.155.10.1137.'}, {'pmid': '21081729', 'type': 'BACKGROUND', 'citation': 'Coker TR, Chan LS, Newberry SJ, Limbos MA, Suttorp MJ, Shekelle PG, Takata GS. Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review. JAMA. 2010 Nov 17;304(19):2161-9. doi: 10.1001/jama.2010.1651.'}, {'pmid': '20522607', 'type': 'BACKGROUND', 'citation': 'Grubb MS, Spaugh DC. Treatment failure, recurrence, and antibiotic prescription rates for different acute otitis media treatment methods. Clin Pediatr (Phila). 2010 Oct;49(10):970-5. doi: 10.1177/0009922810370363. Epub 2010 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to provide preliminary data to support future studies to demonstrate that the short wave infrared (SWIR) otoscope is a better diagnostic tool than a white light otoscope for diagnosing middle ear infections (otitis media). Patients who are having a tympanostomy tube placement procedure will be participating in this study. Imaging will be performed with the white light otoscope and the SWIR otoscope to determine presence of absence of fluid. The SWIR otoscope will gather SWIR data and white light data simultaneously. As part of standard of care, patients who come in for this procedure have removal of middle ear fluid as part of their procedure, which will confirm presence or absence of fluid.', 'detailedDescription': 'Millions of children worldwide obtain an antibiotic prescription for treatment of an ear infection (otitis media), and this has been ranked in the top five conditions for direct medical spending for those under 18 years of age. Otitis media is responsible for the vast majority of tympanostomy tube placements, the most common surgical procedure in the US in children with over 600,000 cases per year. Otitis media is inadequately diagnosed and consequently mistreated. Diagnosis is estimated at 51% for US pediatricians, with over-diagnosis occurring 26% of the time. Accurate diagnosis of otitis media can be an issue as it requires a physician to differentiate between various forms of middle ear conditions. The standard of care (SOC) for diagnosing otitis media is pneumotoscopy by eye or using a white light video otoscope. This technique has advantages, but it suffers from subjective interpretations, especially in the hands of inexperienced practitioners. Our team developed the first otoscope sensitive to short wave infrared (SWIR) light for objective identification of middle ear effusions. The SWIR otoscope collects both the information normally seen by a white light otoscope, and SWIR light. The goal with this research is to evaluate the SWIR otoscope against the white light otoscope currently used as the standard of care diagnostic tool in clinic settings. Patients who are undergoing a tympanostomy tube placement procedure will be eligible for this study. In the operating room, imaging will be performed with the SWIR otoscope, which will gather images of both SWIR data and white light data simultaneously. As part of SOC, patients who come into the operating room for the procedure will have removal of middle ear fluid as part of the procedure. The physician performing the procedure will take note of the presence or absence of middle ear fluid. A different physician and a computer program will analyze the images of the SWIR otoscope for presence or absence of middle ear fluid in the image. These results will be compared with the notes taken during the procedure regarding presence or absence of ear fluid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 1-17\n* Being seen in the Ear, Nose, and Throat Clinic at Lucile Packard Childrens Hospital\n* Undergoing tympanostomy tube placement as part of standard of care\n* Parents and/or patient has the ability to understand and the willingness to sign a written informed consent form or assent form.\n\nExclusion Criteria:\n\n* Patients under 1 year of age or 18 and older\n* Participants not meeting the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06944795', 'briefTitle': 'SWIR Otoscopy Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis', 'orgStudyIdInfo': {'id': 'IRB 44549'}, 'secondaryIdInfos': [{'id': 'R01DC021326', 'link': 'https://reporter.nih.gov/quickSearch/R01DC021326', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SWIR otoscope + white light otoscope', 'description': 'Patients who are undergoing a tympanostomy tube placement as part of standard of care will have their middle ears imaged with the SWIR otoscope. The SWIR otoscope will record images/recordings of the SWIR otoscope and the white light otoscope, therefore, there will only be one arm of the study because all patients will be imaged with the white light and the SWIR.', 'interventionNames': ['Device: SWIR device']}], 'interventions': [{'name': 'SWIR device', 'type': 'DEVICE', 'description': 'A Short Wave Infrared (SWIR) Otoscope will record images for both the SWIR and white light video otoscopes. These images of the middle ear will be recorded in AVI format.', 'armGroupLabels': ['SWIR otoscope + white light otoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Tulio Valdez, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'contacts': [{'name': 'Diego Preciado, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Tulio Valdez, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Otolaryngology - Head & Neck Surgery', 'investigatorFullName': 'Tulio Valdez', 'investigatorAffiliation': 'Stanford University'}}}}