[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588699":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":25,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":20,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":88,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Stanford University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SWIR otoscope + white light otoscope","EXPERIMENTAL","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\u002Frecordings 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.",[13],"Device: SWIR device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","SWIR device","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.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Tulio Valdez, MD, MSc","PRINCIPAL_INVESTIGATOR",[26,40],{"facility":5,"status":20,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Palo Alto","California","94304","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-122.14302,37.44188,{"lat":36,"lon":35},[39],{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":41,"status":20,"city":42,"state":43,"zip":44,"country":30,"countryCode":31,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Children's National Hospital","Washington D.C.","District of Columbia","20010",{"type":33,"coordinates":46},[47,48],-77.03637,38.89511,{"lat":48,"lon":47},[51],{"name":52,"role":24,"phone":20,"phoneExt":20,"email":20},"Diego Preciado, MD, PhD",{"type":24,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Tulio Valdez","Professor of Otolaryngology - Head & Neck Surgery",[57],{"name":58,"class":59},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100588699","swir-otoscopy-study-100588699",false,"NCT06944795","SWIR Otoscopy Study","A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis","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\u002For 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","ALL","1 Year","17 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78,79,80],"Otitis Media","Otitis Media Chronic","Otitis Media Effusion",[82,83,84,85,86,87],"middle ear infections","ear infections","pediatric ear infections","otitis media","chronic otitis media","chronic otitis media with effusion","NOT_YET_RECRUITING","2025-04-25",{"date":91,"type":92},"2025-04-30","ACTUAL",{"date":94,"type":72},"2025-05-01",{"date":96,"type":72},"2027-01",{"name":5,"class":6},2]