[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"otitis-media-with-effusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:otitis-media-with-effusion":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100466425","coherent-optical-detection-of-middle-ear-disease-100466425",false,"NCT05353569","Coherent Optical Detection of Middle Ear Disease","Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease","OCTII","Inclusion Criteria:\n\n* Parental complaint of ear infection or ear pain (Children's Wisconsin Urgent Care Clinics) OR referred for evaluation of otitis media with effusion (Children's Wisconsin ENT Clinic)\n* Speak English\n\nExclusion Criteria:\n\n* Children with craniofacial abnormalities\n* Children with diagnosed immunologic abnormalities\n* Children with congenital syndromic conditions\n* Current open and functioning ear tubes","ALL","12 Months","6 Years",{"count":21,"type":22},235,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this project is to see if optical coherence tomography (OCT), a new technology acting as an ultrasound for the ear, facilitates accurately diagnosing acute otitis media (AOM) and otitis media with effusion (OME) in children. Clinical diagnoses made using solely otoscopy will be compared to those made with the addition of OCT.",[28,29,30],"Otitis Media","Otitis Media With Effusion","Otitis Media Acute","RECRUITING","2026-01-20",{"date":34,"type":35},"2026-01-21","ACTUAL",{"date":37,"type":35},"2022-05-24",{"date":39,"type":22},"2028-04",{"name":41,"class":42},"Medical College of Wisconsin","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100509565","evaluation-of-outcomes-following-in-office-tympanostomy-using-the-tula-system-a-prospective-multi-center-registry-100509565","NCT05915078","Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Inclusion Criteria:\n\n* Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System\n* Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use\n\nExclusion Criteria:\n\n* Patients who are wards are not included","6 Months","17 Years",{"count":54,"type":22},200,"2 Years","OBSERVATIONAL","This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.\n\nThe FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).",[29,59,28],"Acute Otitis Media",[61,62,63,64,65],"Otitis media","pediatric","tympanostomy","office procedure","local anesthesia","2024-07-19",{"date":68,"type":35},"2024-07-23",{"date":70,"type":35},"2023-06-15",{"date":72,"type":22},"2027-06-30",{"name":74,"class":75},"Smith & Nephew, Inc.","INDUSTRY",6,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100480411","sound-ear-check-sec-in-hearing-diagnostics-in-young-children-100480411","NCT05535634","Sound Ear Check (SEC) in Hearing Diagnostics in Young Children","Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion","Inclusion Criteria:\n\n* Finnish speaking (child and parent)\n\nExclusion Criteria:\n\n* Prior sensorineural hearing loss\n* developmental disorder\n* Prior ear surgery (except tympanostomy insertion)",true,"3 Years","10 Years",{"count":88,"type":22},100,"Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.",[91,29,92],"Hearing Loss","Tympanostomy","2022-09-07",{"date":95,"type":35},"2022-09-10",{"date":97,"type":35},"2022-08-31",{"date":99,"type":22},"2028-12-31",{"name":101,"class":102},"Vesa Lahdes","OTHER_GOV",1]