[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557765":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":30,"collaborators":20,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":20,"eligibilityCriteria":39,"healthyVolunteers":36,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":54,"whyStopped":20,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":20},{"fullName":5,"class":6},"HaEmek Medical Center, Israel","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcanal tympanoplasty under local anasthesia with fat graft and \"Tachosil\"","EXPERIMENTAL","eligibale participatns with chronic tympanic membrane perforation will be offered to participate.\n\nUnder local anesthesia, subcutaneous fat from the neck will be harvested. After that trimming of the perforation edges, planting the fat graft medial to the tympanic membrane and placement of the \"Tachosil\" on top of the fat graft.\n\ngelfoam is placed lateral to the tympanic membrane fo fill the ear canal. follow-up will be held at 2, 4-6 and 12 month following the procedure, with audiometric and otological evaluation",[13],"Procedure: Tympanoplasty performed under local anesthesia using fat graft and \"Tachosil\".",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Tympanoplasty performed under local anesthesia using fat graft and \"Tachosil\".","Under local anesthesia, subcutaneous fat from the neck will be harvested. After that trimming of the perforation edges, planting the fat graft medial to the tympanic membrane and placement of the \"Tachosil\" on top of the fat graft.\n\ngelfoam is placed lateral to the tympanic membrane to fill the ear canal. follow-up will be held at 2, 4-6 and 12 months following the procedure, with audiometric and otological evaluation",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"yoni Evgeni Gutkovich, M.D\u002FPh.D","CONTACT","+972-46495563","yonigo@clalit.org.il",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Lev Shlizerman, M.D","lev_sh@clalit.org.il",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Yoni Evgeni Gutkovich","Doctor","100557765","trans-canal-tympanoplasty-with-local-anesthesia-using-fat-graft-and-tachosil-100557765",false,"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","ALL","18 Years","99 Years",{"count":44,"type":45},20,"ESTIMATED","INTERVENTIONAL",[48],"NA","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.",[51],"Tympanic Membrane Perforation",[53],"Tympanoplasty","NOT_YET_RECRUITING","2024-08-12",{"date":57,"type":58},"2024-08-13","ACTUAL",{"date":60,"type":45},"2024-09-01",{"date":62,"type":45},"2026-09-01",{"name":5,"class":6}]