[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550919":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":34,"responsibleParty":49,"collaborators":51,"id":56,"slug":24,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":24,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":36,"whyStopped":24,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cochleostomy","ACTIVE_COMPARATOR","When employing the cochleostomy approach, a carefully positioned opening will be drilled anterior-inferior to the eRW membrane.",[13],"Procedure: Surgical approach: cochleostomy or extended round window",{"label":15,"type":10,"description":16,"interventionNames":17},"extended Round Window","In case of the extended round window approach, the scala tympani will be accessed through the extended round window technique, involving the creation of a round window margin cochleostomy.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Surgical approach: cochleostomy or extended round window","Surgical placement of a cochlear implant electrode array",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Coby Lindeboom, MD","CONTACT","024 361 14934","Coby.lindeboom@radboudumc.nl",{"name":32,"role":28,"phone":24,"phoneExt":24,"email":33},"Emmanuel Mylanus","Emmanuel.Mylanus@radboudumc.nl",[35],{"facility":5,"status":36,"city":37,"state":24,"zip":24,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Nijmegen","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],5.85278,51.8425,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":24,"phoneExt":24,"email":30},"Lindeboom",{"type":50,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[52,54],{"name":53,"class":6},"GZA Ziekenhuizen Campus Sint-Augustinus",{"name":55,"class":6},"Universitaire Ziekenhuizen KU Leuven","100550919",false,"NCT06453343","Clinical Trial to Compare Two Surgical Approaches to the Cochlea","Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode: Assessing Intracochlear Trauma Using Intraoperative Electrocochleography Measurements and Preservation of Residual Hearing","BULLS-I","Inclusion Criteria:\n\n* Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.\n* CI candidate based on local or national reimbursement criteria.\n* Cochlear implantation with a CI632.\n* Preoperative 500 Hz pure-tone air conduction threshold \\\u003C80 dB hearing level (HL) in the ear to be implanted.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Previous or existing CI recipient.\n* Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.\n* Abnormal cochlear nerve anatomy on preoperative CT or MRI.\n* Subjects who are unable to undergo CT or MRI.\n* Deafness due to acoustic nerve or central auditory pathway lesions.\n* Diagnosis of auditory neuropathy.\n* Active middle ear infection.\n* Additional handicaps that would prevent participation in study evaluations.\n* Unrealistic expectations from the participant regarding the possible benefits, risks, and limitations inherent to the CI procedure and the investigation.\n* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.","ALL","18 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70],"NA","This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.",[73,74],"Cochlear Implants","Hearing Loss, Sensorineural",[76,77,9,78,79,80],"Surgical approach","Round Window","Electrocochleography","Imaging","Residual hearing preservation","2025-02-21",{"date":83,"type":84},"2025-02-25","ACTUAL",{"date":86,"type":84},"2025-01-01",{"date":88,"type":67},"2027-11",{"name":5,"class":6},1]