[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tympanic-membrane-perforation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tympanic-membrane-perforation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,93,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":46,"locationsCount":49},"100572873","otological-study-of-facial-cleft-patients-over-10-years-of-age-excluding-isolated-cleft-lip-efeof-100572873",false,"NCT06738927","Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip) (EFEOF)","Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip)","EFEOF","Inclusion Criteria:\n\nPresence of a facial cleft between 2004 and 2014 Minor and adult patients Followed up by ENT services at the University Hospital of Brest or Marseille\n\nExclusion Criteria:\n\nPatients under legal protection (guardianship, curatorship, etc.) Refusal to participate Objection from one of the parents Isolated cleft lip No ENT follow-up","ALL","10 Years",{"count":20,"type":21},500,"ESTIMATED","OBSERVATIONAL","Studies published on the placement of transtympanic ventilatory tubes in children with cleft palate show heterogeneous results, highlighting the need for a new study with strong statistical power and long-term follow-up to clarify the real benefits of this intervention.\n\nMirashrafi (2022) and Maina (2022), for example, emphasize the current uncertainties regarding the management of otitis media with effusion in children with cleft palate. Mirashrafi conducted a study on 40 children and found no significant difference between those with a complete cleft palate and those with an incomplete cleft palate in terms of middle ear status after the placement of transtympanic ventilatory tubes. Maina, in an ongoing review, identified a lack of consensus on the optimal management of chronic otitis media with effusion, with outcomes being varied and often of low methodological quality.\n\nThe absence of convincing evidence justifies the need for further research to establish clear guidelines. The objective is to study the otological status of patients based on the presence or absence of ENT surgical management involving the placement of transtympanic ventilatory tubes.",[25,26,27,28,29,30,31,32],"Serous Otitis","Tympanic Membrane Perforation","Retraction Pocket","Cholesteatoma","Otorrhea","Myringosclerosis","Tympanosclerosis","Audiometric Tests",[34,35,36,37],"Serous otitis Tympanic membrane perforation Retraction pocket Cholesteatoma otorrhea Myringosclerosis Tympanosclerosis Audiometric tests","ENT","transtympanic ventilatory tubes.","cleft palate","NOT_YET_RECRUITING","2024-12-13",{"date":41,"type":42},"2024-12-18","ACTUAL",{"date":44,"type":21},"2024-12-12",{"date":44,"type":21},{"name":47,"class":48},"University Hospital, Brest","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"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","18 Years",{"count":59,"type":21},44,"INTERVENTIONAL",[62],"NA","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.",[26,65,66,67],"Tympanic Membrane Inflammation","Surgery","Otitis Media",[69,70,71,72,73,74,75,76,77,78,79,80],"tympanic membrane","surgery","single blinded","chitogel","chitosan-dextran","otitis media","gelfoam","medical device","chitodex","myringoplasty","mastoidectomy","ossiculoplasty","RECRUITING","2024-11-11",{"date":84,"type":42},"2024-11-13",{"date":86,"type":42},"2021-11-20",{"date":88,"type":21},"2025-05-13",{"name":90,"class":91},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",2,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":17,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":60,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":92},"100504554","tympanoseal-clinical-study-100504554","NCT05849844","Tympanoseal Clinical Study","Tympanoseal (Tympanic Membrane Device) Clinical Study","Inclusion Criteria:\n\n1. Male or female patients over 2 years of age at enrollment\n2. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.\n3. Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study\n\nExclusion Criteria:\n\n1. Active otorrhea or otitis media\n2. Otorrhea or otitis media within 4 weeks prior to the operation\n3. History of cholesteatoma\n4. Perforations on the edge of the tympanic membrane\n5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data\n6. Subject is taking systemic\u002Foral corticosteroids\n7. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal",true,"2 Years","100 Years",{"count":104,"type":21},45,[62],"The purpose of this investigational study is to assess the ability of Tympanoseal (sodium\u002Fcalcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.",[26],"2024-10-14",{"date":110,"type":42},"2024-10-15",{"date":112,"type":42},"2024-01-05",{"date":114,"type":21},"2026-04-20",{"name":116,"class":117},"Grace Medical, Inc.","INDUSTRY",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":60,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100557765","trans-canal-tympanoplasty-with-local-anesthesia-using-fat-graft-and-tachosil-100557765","NCT06542367","Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and \"TachoSil\"","Inclusion Criteria:\n\n* Chronic tympanic membrane perforation (\\>6 months).\n* Central tympanic membrane perforation.\n* Air bone gar of 35 dB or lower at the operated ear.\n* No active otorrhea in the operated ear in the preceding 3 month prior to the procedure.\n* No evidence of a retraction pocket and no suspicion for a cholesteatoma.\n\nExclusion Criteria:\n\n* Known ossicular chain dysfunction\n* The tympanic membrane perforation edges are not accessible\u002Fvisualized transcanal\n* Pregnancy\n* Allergy to lidocaine","99 Years",{"count":126,"type":21},20,[62],"Eligible participants with chronic tympanic membrane perforation (\\>6 month) will be given a detailed description and offered to participate in the study.\n\nthe study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and \"Tachosil\". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.",[26],[131],"Tympanoplasty","2024-08-12",{"date":134,"type":42},"2024-08-13",{"date":136,"type":21},"2024-09-01",{"date":138,"type":21},"2026-09-01",{"name":140,"class":48},"HaEmek Medical Center, Israel"]