[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"otitis-media\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:otitis-media":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,77,104,128,153,174,201,236,258,286,322],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100643164","parent-led-assessment-and-recognition-of-aom-using-digital-ear-imaging-100643164",false,"NCT07640568","Parent-led Assessment and Recognition of AOM Using Digital Ear Imaging","PARENT-EAR","Inclusion Criteria:\n\n* At least one episode of AOM within the last 12 months\n* Family speaks fluent Finnish\n\nExclusion Criteria:\n\n* Tympanostomy tubes or perforation of the TM, or scheduled for upcoming tympanostomy\n* Middle ear fluid at the time of recruitment\n* Previously diagnosed hearing loss\n* Immunosuppressive disorder or medication, excluding inhaled corticosteroids\n* Anatomic defect or anomaly affecting the susceptibility to AOM\n* Previous otoscopy experience of the participating parent",true,"ALL","12 Months","47 Months",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","Acute otitis media (AOM) is the most common bacterial infection in young children and a major contributor to healthcare utilization and costs. Diagnosis relies on otoscopy and identification of tympanic membrane (TM) bulging, yet physician-performed otoscopy has variable diagnostic accuracy and depends heavily on clinical expertise.\n\nDigital otoscopy combined with artificial intelligence (AI)-based image analysis has demonstrated high diagnostic accuracy in previous studies. In a recent study by our group, digital otoscopy with an automated neural network classifier reliably ruled out otitis media in children.\n\nThe PARENT-EAR randomized controlled pilot trial aims to evaluate whether parent-performed digital otoscopy at home, combined with retrospective AI analysis of captured TM images, can reduce physician visits due to suspicion of AOM. The study also assesses feasibility, diagnostic accuracy of parents after training, and potential effects on antibiotic use and healthcare utilization.\n\nMethods and outcomes The PARENT-EAR trial is a randomized controlled pilot trial conducted at Vaasa Central Hospital and Turku University Hospital. Recruitment will occur between September and December 2026 (extended if necessary), with follow-up ending May 31, 2027 (5-9 months per participant).\n\nChildren aged 12 to 47 months with at least one AOM episode in the past 12 months will be randomized 1:1 using permuted block randomization. Exclusion criteria include tympanostomy tubes, tympanic membrane perforation, middle ear effusion at recruitment, immunosuppression, previously diagnosed hearing loss or anatomical abnormalities predisposing to AOM, and otoscopy experience of the parent.\n\nIntervention group:\n\nParents receive a digital otoscope (The Ear Penguin by Sibbo Medical Devices, MDR EU Class I device) and training on TM image interpretation. They complete a TM image classification quiz before and after the training. During follow-up, parents perform home otoscopy when suspecting AOM, capture TM images\u002Fvideos, interpret findings, and record symptoms in a diary. If AOM is suspected or the child appears ill, medical evaluation is instructed.\n\nControl group:\n\nStandard care without home otoscopy. Parents complete the same symptom diary and seek care according to usual practice.\n\nStatistical analyses will compare outcomes between groups. AI-based TM classification will be compared against expert panel evaluation.\n\nThis is a pilot study with a target sample size of 20 children per arm, limited by device availability.\n\nEthical aspects, data collection and handling The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all parents after provision of oral and written information. Participation is voluntary, and families may withdraw at any time. Investigators may discontinue participation if deemed in the child's best interest.\n\nThe digital otoscope is a CE-marked Class I medical device used solely for visual inspection of the tympanic membrane. Pneumatic pumps are not provided. Potential risks include minor ear canal abrasions or discomfort; serious adverse events are considered rare. Any adverse events will be managed according to standard clinical practice and reported to relevant authorities when required. The study is investigator-initiated. The device manufacturer provides the otoscopes but has no role in study design, data access, or analysis.\n\nData will be collected via paper symptom diaries, monthly REDCap questionnaires (University of Turku), and national electronic health records (Kanta). TM images and videos will be securely stored and imported into a research database with relevant metadata.\n\nAll data will be handled in accordance with the EU General Data Protection Regulation (GDPR 2016\u002F679). Study data will be pseudonymized and identified only by study ID numbers. The key linking personal identifiers to study IDs will be stored separately and securely. Paper diaries will be destroyed after digitalization. Consent includes permission to access health records and to use collected images and data for scientific purposes. Results will be published in peer-reviewed journals and as part of a doctoral thesis.",[28,29],"Acute Otitis Media","Otitis Media",[31,32,33,34],"acute otitis media","otitis media","digital otoscopy","telemedicine","NOT_YET_RECRUITING","2026-06-06",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":22},"2026-09-01",{"date":43,"type":22},"2027-08-31",{"name":45,"class":46},"Turku University Hospital","OTHER_GOV",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100642730","osteopathic-manipulative-treatment-for-children-with-chronic-or-recurrent-otitis-media-100642730","NCT07639775","Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media","The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 6 months to less than 7 years. (All participants)\n* Referred to an otolaryngologist (ENT) for evaluation of chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). (All participants)\n* Planned for tympanostomy tube placement (unilateral or bilateral) pending surgical decision. (All participants)\n* At least 5 weeks between enrollment and anticipated surgical decision point. (All participants)\n\nExclusion Criteria:\n\n* Congenital or developmental conditions associated with increased otitis media risk, including but not limited to Down syndrome, cleft palate, or other craniofacial abnormalities. (All participants)\n* History of prior tympanostomy tube placement or current tympanostomy tubes in place. (All participants)\n* History of tympanic membrane perforation. (All participants)\n* Presence of preauricular pits. (All participants)\n* Patients requiring urgent or expedited surgical intervention, as determined by the treating ENT physician. (All participants)","6 Months","6 Years",{"count":58,"type":22},200,[25],"The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement.\n\nThe main question it aims to answer is:\n\nCan a standardized OMT protocol, given once weekly for 4 weeks before the final surgical decision, reduce the rate of tympanostomy tube surgery in pediatric patients with recurrent or chronic otitis media?\n\nResearchers will compare children who receive the standardized OMT protocol with children who receive a placebo\u002Fcontrol manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery.\n\nParticipants will:\n\n* Attend 4 weekly study visits before their final ENT surgical decision.\n* Receive one of several assigned combinations of standardized OMT intervention procedures and control manual procedures. Each participant's assigned treatment sequence is determined by randomization.\n* Complete study-related assessments and questionnaires related to ear symptoms and quality of life.\n* Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.",[29,62,63,64,65,66,67,68],"Otitis Media Effusion","Otitis Media Recurrent","Otitis Media With Effusion in Children","Otitis Media Chronic","Otitis Media in Children","Tympanostomy Tube Insertion","Osteopathic Manipulative Treatment (OMT)",{"date":38,"type":39},{"date":71,"type":22},"2026-08-01",{"date":73,"type":22},"2028-05-31",{"name":75,"class":76},"Sarah Vidal","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100639335","clikx-tympanostomy-tube-delivery-system-for-the-placement-of-tympanostomy-tubes-100639335","NCT07625657","CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes","A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes","Inclusion Criteria:\n\n1. Subject is scheduled to undergo tympanostomy tube insertion.\n2. Subject is ≥ 6 months old at the time of informed consent.\n3. Subject has an ear canal diameter of ≥ 4 mm.\n4. Subject is able and willing to provide informed consent or subject's parent\u002Fguardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to 21 years old).\n\nExclusion Criteria:\n\n1. Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice.\n2. Subjects with known adverse reaction to anesthesia.\n3. Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.\n4. Subjects with otitis externa.\n5. Subjects with active acute otitis media.\n6. Subjects with an ear canal diameter \\\u003C 4 mm.\n7. Ear drums that are overly vertical or horizontal\n8. Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.\n9. Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk.\n10. Subjects with suspected middle ear tumors or vascular lesions.\n11. Subjects diagnosed with acute sensorial hearing loss\n12. Subjects with a history of surgery involving the ear drum.\n13. Subjects with hemotympanum.\n14. Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.",{"count":85,"type":22},80,[25],"This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed.\n\nIn this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia.\n\nThe study will also look at how well patients tolerate the procedure by checking for side affects during the procedure.\n\nFinally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..",[29,65,62,63,66],[32,90,91,92,93],"Tympanostomy tube","NousQ","CLiKX","myringotomy","2026-06-02",{"date":96,"type":39},"2026-06-04",{"date":98,"type":22},"2026-06",{"date":100,"type":22},"2027-08",{"name":102,"class":103},"ClinQure, Inc.","NETWORK",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":124,"locationsCount":127},"100627890","evaluating-laser-otoscope-for-middle-ear-effusion-detection-100627890","NCT07454512","Evaluating Laser Otoscope for Middle Ear Effusion Detection","Evaluation of an Investigational Laser Otoscope for Detection of Middle Ear Effusion in Pediatric Patients","Inclusion Criteria:\n\n* Scheduled to undergo unilateral or bilateral myringotomy with ear tube placement\n* Between the ages of 6 months to 18 years at the time of consent\n* Able to provide assent as judged by the investigator or delegated personnel, and their parent(s) or legal guardian(s) has signed the current Institutional Review Board (IRB) approved informed consent form along with the HIPAA Authorization for the use and release of Private Health Information (PHI) or applicable privacy protection\n\nExclusion Criteria:\n\n* History of prior ear tube placement\n* Anatomical abnormalities of the tympanic membrane or ear canal\n* Presence of excessive cerumen that cannot be removed pre-exam and may interfere with study procedures\n* Any of the following deformities of the external ear and tympanic membrane: congenital canal stenosis or atresia, severe canal tortuosity or curvature which prevents visualizing the tympanic membrane fully with an otoscope, canal wall exostoses or osteomas, markedly thickened or opaque tympanic membranes such as caused by chronic myringitis, or scarring or fibrosis of the tympanic membrane, tympanosclerosis or other heavy calcification of the tympanic membrane, tympanic membrane perforations, and grafted tympanic membranes.","18 Years",{"count":113,"type":22},150,"OBSERVATIONAL","The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are:\n\n-Accuracy and usability of doctors using laser otoscopes\n\nParticipants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.",[117,29],"Middle Ear Effusion","2026-03-02",{"date":120,"type":39},"2026-03-06",{"date":122,"type":22},"2026-03-01",{"date":41,"type":22},{"name":125,"class":126},"MSTATT LLC","INDUSTRY",1,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":47},"100466425","coherent-optical-detection-of-middle-ear-disease-100466425","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",{"count":137,"type":22},235,[25],"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.",[29,141,142],"Otitis Media With Effusion","Otitis Media Acute","RECRUITING","2026-01-20",{"date":146,"type":39},"2026-01-21",{"date":148,"type":39},"2022-05-24",{"date":150,"type":22},"2028-04",{"name":152,"class":76},"Medical College of Wisconsin",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":160,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100611631","validating-and-ai-software-for-assessment-of-children-with-ear-concerns-100611631","NCT07243093","Validating and AI Software for Assessment of Children With Ear Concerns","Validating a Deep Learning Algorithm in Children With Ear Concerns","Inclusion Criteria:\n\n* Males and females aged 6 months to 6 years\n* Presenting to a pediatrician's office or urgent care with signs and symptoms of otitis media, including tugging at ears, ear pain, crying at night, refusing to lie flat, sleeping poorly, having a fever, having decreased appetite, and\u002For concern for hearing loss, regardless of previous diagnosis of AOM or OME.\n\nExclusion Criteria:\n\n* History of craniofacial abnormality\n* PE tubes currently in place\n* Current otorrhea\n* Caretaker not having use of both hands and arms",{"count":161,"type":22},658,"The goal of this observational study is to determine if the Glimpse machine learning algorithm can accurately assess ear diseases in children. Participants will:\n\n* Have a video of their ear taken by their parent or their guardian\n* Have a video of their ear taken by a Primary Care Physician (PCP)\n* Have an assessment of their eardrums and a video of their ears taken by an Ear, Nose, and Throat specialist (ENT).\n\nThe videos will be used to determine if the Glimpse algorithm matches the diagnosis of the physicians.",[164,29,62],"Otalgia","2025-11-17",{"date":167,"type":39},"2025-11-21",{"date":169,"type":22},"2026-01",{"date":171,"type":22},"2027-07",{"name":173,"class":126},"Glimpse Diagnostics, Inc.",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":4},"100607516","phase-3-intranasal-corticosteroid-spray-for-preventing-otitis-media-with-effusion-after-radiotherapy-in-nasopharyngeal-carcinoma-100607516","NCT07189572","Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma","Efficacy of Intranasal Corticosteroid Spray in Preventing Otitis Media With Effusion After Radiotherapy for Nasopharyngeal Carcinoma: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial","Inclusion Criteria:\n\n* Pathologically confirmed nasopharyngeal carcinoma scheduled for curative intensity-modulated radiation therapy (IMRT), with or without concurrent chemotherapy.\n* Age between 18 and 75 years.\n* No previous history of head and neck radiotherapy.\n* Intact tympanic membranes bilaterally at baseline, with no history of middle ear surgery (including tympanostomy tube placement).\n* Willing to comply with all study procedures, including nasal spray use, audiological examinations, and follow-up visits.\n* No use of systemic or topical corticosteroids, antihistamines, or decongestants within 14 days prior to randomization.\n* All inclusion criteria must be met for participation\n\nExclusion Criteria:\n\n* Diagnosed with complete conductive hearing loss or ossicular chain fixation.\n* Scheduled to undergo tympanostomy tube placement, tympanotomy, or other middle ear surgery prior to randomization.\n* Unlikely to complete the 12-month follow-up (e.g., planned relocation, poor compliance).\n* Presence of respiratory conditions requiring treatment with nasal corticosteroids.\n* Known allergy or hypersensitivity to nasal corticosteroids (especially triamcinolone acetonide or its excipients).\n* History of severe mental illness, cognitive impairment, or substance abuse that may affect compliance.\n* Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.\n* Participation in other investigational drug clinical trials within the past 3 months.\n* Deemed unsuitable for the trial by the investigator (e.g., severe septal deviation, chronic rhinosinusitis requiring systemic treatment, or poorly controlled diabetes).\n* Any subject who meets any of the above exclusion criteria at baseline will be excluded from the study.","75 Years",{"count":183,"type":22},168,[185],"PHASE3","This study focuses on a common side effect experienced by many patients after radiation therapy for nasopharyngeal cancer, which is a type of head and neck cancer. This side effect is called secretory otitis media (fluid buildup in the middle ear). It can cause a feeling of fullness in the ear and hearing loss. While procedures like ear tube placement can help, they can also lead to other problems like ear infections and drainage.\n\nRadiation treatment is thought to cause inflammation that disrupts the normal function of the tube connecting the ear to the throat (Eustachian tube), leading to this fluid buildup. A nasal spray containing a steroid medicine (triamcinolone acetonide) is already known to be safe and effective at reducing inflammation in the ear fluid of both children and adults. We believe that using this spray may also help prevent and improve this condition in nasopharyngeal cancer patients after radiation therapy.\n\nThe main goal of this study is to explore whether this nasal spray can effectively prevent or reduce fluid buildup in the ear following radiation therapy. We hope this non-invasive treatment will provide a new option to improve the quality of life for these patients.",[29,188,189,190,191],"Otitis Media With Effusion After Nasopharyngeal Carcinoma","Radiotherapy Side Effects","Radiotherapy Side Effect","Otitis Media With Effusion (OME)","2025-09-23",{"date":194,"type":39},"2025-09-29",{"date":196,"type":22},"2025-10",{"date":198,"type":22},"2027-10",{"name":200,"class":76},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":222,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":127},"100600150","perspectives-on-antibiotics-and-tracking-symptoms-in-children-100600150","NCT07093749","Perspectives on Antibiotics and Tracking Symptoms in Children","PATSy Perspectives on Antibiotics and Tracking Symptoms in Children - a Mixed Methods Feasibility Study","PATSy","Inclusion Criteria:\n\n* Between the ages of ≥ 4 years and ≤ 17 years at enrolment.\n* Diagnosed with any of the following at RCH ED: urinary tract infection (UTI), cellulitis, impetigo, pharyngitis, tonsillitis, respiratory tract infections, otitis media.\n* Prescribed oral antibiotics (either immediately or as switch from IV antibiotics after transfer to HITH) as standard of care due to having uncomplicated infection as deemed by their treating doctor.\n* Parent\u002Fguardian provides a signed and dated informed consent form.\n\nExclusion Criteria:\n\n\\- Parent\u002Fguardian does not speak English","4 Years","17 Years",{"count":212,"type":22},300,[25],"The study will assess families' perspectives and decision-making regarding the duration of oral antibiotic courses prescribed to children (4-17 years) who present with uncomplicated bacterial infections at the Royal Children's Hospital (RCH) Emergency Department (ED). The study will involve (i) children discharged from ED on oral antibiotics and (ii) children transferred to Hospital-in-the-Home (HITH) on IV antibiotics who then switch to oral antibiotics. In addition, the study will assess how feasible and acceptable it is to track children's symptoms via the Garmin Smartwatch and the WeGuide platform (WeGuide is a patient engagement software platform that allows for enrolment, consent, and data collection \\[via questionnaires\u002Fsurveys and from the Garmin Smartwatches\\] through a singular platform).",[216,217,218,219,220,221,29],"Urinary Tract Infection","Cellulitis","Impetigo","Pharyngitis","Tonsillitis","Respiratory Tract Infections",[223,224,225,226],"Paediatrics","Antibiotics","Digital Health","Infection","2025-09-17",{"date":229,"type":39},"2025-09-22",{"date":231,"type":39},"2025-09-16",{"date":233,"type":22},"2026-08",{"name":235,"class":76},"Murdoch Childrens Research Institute",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":4},"100595249","post-market-clinical-follow-up-study-of-the-solo-tympanostomy-tube-device-100595249","NCT07029997","Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device","Inclusion Criteria:\n\n* Subject and\u002For Parent\u002FGuardian is able to understand the information document and (depending in the country's legislation) does not object participating or is willing to provide documented informed consent\n* Subject was or will be treated, or had a treatment attempted with the study device.\n\nExclusion Criteria:\n\n* None",{"count":243,"type":22},160,"The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents\u002Fguardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.",[29,246],"Middle Ear Infections",[248],"ear tubes","2025-06-12",{"date":251,"type":39},"2025-06-19",{"date":253,"type":22},"2025-07",{"date":255,"type":22},"2029-07",{"name":257,"class":126},"AventaMed DAC",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":265,"maxAge":210,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":47},"100588699","swir-otoscopy-study-100588699","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","1 Year",{"count":267,"type":22},100,[25],"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.",[29,65,62],[272,273,274,32,275,276],"middle ear infections","ear infections","pediatric ear infections","chronic otitis media","chronic otitis media with effusion","2025-04-25",{"date":279,"type":39},"2025-04-30",{"date":281,"type":22},"2025-05-01",{"date":283,"type":22},"2027-01",{"name":285,"class":76},"Stanford University",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":301,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":47},"100536114","effect-of-chitodex-gel-in-tympanoplasty-surgery-100536114","NCT06260618","Effect of Chitodex Gel in Tympanoplasty Surgery","A Single-blinded Randomised Trial Evaluating the Efficacy of Chitosan-dextran (Chitodex) Gel Versus Gelfoam Sponge Instillation Within the Middle Ear and External Auditory Canal During Tympanoplasty Surgery","Inclusion Criteria:\n\n1. Individuals who have otoscopic evidence of tympanic membrane perforation that is also confirmed by tympanometry (Defined as a Type B tympanogram, with elevated EAC volume) AND\n\n   1. The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND\n   2. Are indicated to undergo closure of the perforation via tympanoplasty surgery\n2. OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae\n3. OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma\n4. Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND\n5. Are 18 years of age or over AND\n6. Are able to give written informed consent AND\n7. Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op\n\nExclusion Criteria:\n\n1. Operative ear is the better or only hearing ear\n2. The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination\n3. dysfunction during otoscopic and tympanometric examination\n4. Known allergy to shellfish or ciprofloxacin antibiotics\n5. Pregnant or breastfeeding\n6. Hepatitis, HIV or any blood disorders\n7. COVID-19 positive patients\n8. Contra-indications for MRI",{"count":294,"type":22},44,[25],"The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.",[298,299,300,29],"Tympanic Membrane Perforation","Tympanic Membrane Inflammation","Surgery",[302,303,304,305,306,32,307,308,309,310,311,312],"tympanic membrane","surgery","single blinded","chitogel","chitosan-dextran","gelfoam","medical device","chitodex","myringoplasty","mastoidectomy","ossiculoplasty","2024-11-11",{"date":315,"type":39},"2024-11-13",{"date":317,"type":39},"2021-11-20",{"date":319,"type":22},"2025-05-13",{"name":321,"class":46},"Central Adelaide Local Health Network Incorporated",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":210,"enrollmentInfo":329,"targetDuration":330,"studyType":114,"phases":4,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":348},"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",{"count":58,"type":22},"2 Years","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).",[141,28,29],[334,335,336,337,338],"Otitis media","pediatric","tympanostomy","office procedure","local anesthesia","2024-07-19",{"date":341,"type":39},"2024-07-23",{"date":343,"type":39},"2023-06-15",{"date":345,"type":22},"2027-06-30",{"name":347,"class":126},"Smith & Nephew, Inc.",6]