[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536708":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":164,"collaborators":25,"id":166,"slug":167,"hasResults":168,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":168,"sex":174,"minAge":175,"maxAge":25,"enrollmentInfo":176,"targetDuration":25,"studyType":179,"phases":180,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Advanced Bionics AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","ECochG monitored CI surgery incl. corrective action guide",[13],"Procedure: ECochG monitored CI surgery incl. corrective action guide",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Routine CI surgery without ECochG monitoring",[19],"Procedure: Routine CI surgery without ECochG monitoring",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Routine CI surgery with access to ECochG monitoring by surgeon",[15],[30],{"name":31,"affiliation":32,"role":33},"Matt E Smith, Dr","Cambridge University Hospitals NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Unai Martinez de Estibariz, Mr","CONTACT","+34666964128","unai.martinez@advancedbionics.com",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Martina Brendel, Ms","+4915222836491","martina.brendel@advancedbionics.com",[45,64,80,97,114,131,148],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Universitair Ziekenhuis Gent","RECRUITING","Ghent","Gent","9000","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],3.71667,51.05,{"lat":57,"lon":56},[60,62],{"name":61,"role":33,"phone":25,"phoneExt":25,"email":25},"Ingeborg Dhooge, Dr",{"name":63,"role":33,"phone":25,"phoneExt":25,"email":25},"Freya Swinnen, Dr",{"facility":65,"status":47,"city":66,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Le Centre Hospitalier Régional Universitaire de Tours","Tours","37000","France","FR",{"type":54,"coordinates":71},[72,73],0.70398,47.39484,{"lat":73,"lon":72},[76,78],{"name":77,"role":33,"phone":25,"phoneExt":25,"email":25},"David Bakhos, Prof",{"name":79,"role":33,"phone":25,"phoneExt":25,"email":25},"Mathieu Robier, Mr",{"facility":81,"status":47,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Universitätsklinikum Freiburg Klinik","Freiburg im Breisgau","Freiburg","79106","Germany","DE",{"type":54,"coordinates":88},[89,90],7.85222,47.9959,{"lat":90,"lon":89},[93,95],{"name":94,"role":33,"phone":25,"phoneExt":25,"email":25},"Antje Aschendorff, Prof",{"name":96,"role":33,"phone":25,"phoneExt":25,"email":25},"Thomas Wesarg, Dr",{"facility":98,"status":47,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Ospedale Martini","Torino","TO","10141","Italy","IT",{"type":54,"coordinates":105},[106,107],11.99138,44.88856,{"lat":107,"lon":106},[110,112],{"name":111,"role":33,"phone":25,"phoneExt":25,"email":25},"Diego Di Lisi, Dr",{"name":113,"role":33,"phone":25,"phoneExt":25,"email":25},"Patrizia Consolino, Dr",{"facility":115,"status":47,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"World Hearing Center","Warsaw","Nadarzyn","05-830","Poland","PL",{"type":54,"coordinates":122},[123,124],21.01178,52.22977,{"lat":124,"lon":123},[127,129],{"name":128,"role":33,"phone":25,"phoneExt":25,"email":25},"Piotr Skarżyński, Prof",{"name":130,"role":33,"phone":25,"phoneExt":25,"email":25},"Adam Walkowiak, Dr",{"facility":132,"status":47,"city":133,"state":133,"zip":134,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Hospital Universitario Clinico San Cecilio","Granada","18007","Spain","ES",{"type":54,"coordinates":138},[139,140],-3.60667,37.18817,{"lat":140,"lon":139},[143,145],{"name":144,"role":33,"phone":25,"phoneExt":25,"email":25},"Nicolas Müller, Dr",{"name":146,"role":147,"phone":25,"phoneExt":25,"email":25},"Jose Pineda","SUB_INVESTIGATOR",{"facility":32,"status":47,"city":149,"state":150,"zip":151,"country":152,"countryCode":153,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Cambridge","England","CB2 0QQ","United Kingdom","UK",{"type":54,"coordinates":155},[156,157],0.11667,52.2,{"lat":157,"lon":156},[160,162],{"name":161,"role":33,"phone":25,"phoneExt":25,"email":25},"Matthew E Smith, Dr",{"name":163,"role":33,"phone":25,"phoneExt":25,"email":25},"Patrick Axon, Dr",{"type":165,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100536708","hearing-and-structure-preservation-via-ecochg-100536708",false,"NCT06268340","Hearing and Structure Preservation Via ECochG","Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide","PRESERVE","Inclusion Criteria:\n\n* Aged 18 years of age or older\n* Within cochlear implant inclusion criteria by local regulations\u002Fguidelines at the time of implantation\n* Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted\n* Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted\n* Less than 15 years of severe to profound deafness on the implant ear prior to surgery\n* Post-lingually acquired hearing loss in the ear to be implanted\n* Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted\n* Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array\n* Listed for cochlear implant surgery under general anaesthesia\n* Fluent in local language\n* Given informed consent to participate in the study\n\nExclusion Criteria:\n\n* Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted\n* Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted\n* Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections\n* Diagnosis of auditory spectrum neuropathy disorder\n* Deafness due to lesions of the acoustic nerve or central auditory pathway\n* Deafened by meningitis\n* Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL)\n* Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear \\> 30 dB HL and ≤ 55 dB HL)\n* History of previous cochlear implantation\u002Fre-implantation on either ear\n* Any contraindications to computed tomography (CT) scans\n* Concurrent participation in other cochlear implant related studies","ALL","18 Years",{"count":177,"type":178},102,"ESTIMATED","INTERVENTIONAL",[181],"NA","The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.",[184,185],"Hearing Loss, Sensorineural","Severe-to-profound Hearing Loss",[187,188,189,190,191,192,193,194],"Electrocochleography","Hearing Preservation","Structure Preservation","Intra-cochlear monitoring","Scalar translocations","Cochlear Microphonics","Corrective action guide","Cochlear Implants","2026-01-02",{"date":197,"type":198},"2026-01-06","ACTUAL",{"date":200,"type":198},"2024-05-15",{"date":202,"type":178},"2026-12-31",{"name":5,"class":6},7]