[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604232":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":54,"centralContacts":58,"locations":64,"responsibleParty":87,"collaborators":47,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":47,"enrollmentInfo":100,"targetDuration":47,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":67,"whyStopped":47,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14,19,24],{"label":9,"type":6,"description":10,"interventionNames":11},"Group 1: RW and LW","Combination of round window insertion and lateral wall electrode array",[12,13],"Procedure: Round window insertion","Device: Lateral wall array",{"label":15,"type":6,"description":16,"interventionNames":17},"Group 2: RW and PM","Combination of round window insertion and perimodiolar electrode array",[12,18],"Device: Periomodiolar electrode array",{"label":20,"type":6,"description":21,"interventionNames":22},"Group 3: CO and LW","Combination of cochleostomie insertion and lateral wall electrode array",[23,13],"Procedure: Cochleostomy insertion",{"label":25,"type":6,"description":26,"interventionNames":27},"Group 4: CO + PM","Combination of cochleostomy insertion and perimodiolar electrode array",[23,18],[29,36,42,48],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Round window insertion","Insertion of the electrode array via the round window.",[9,15],[35],"Round window",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Cochleostomy insertion","Insertion of the electrode array via cochleostomy.",[20,25],[41],"cochleostomy",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DEVICE","Lateral wall array","Lateral wall electrode array from Advanced Bionics.",[9,20],null,{"type":43,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Periomodiolar electrode array","Perimodiolar MidScala electrode array from Advanced Bionics.",[15,25],[53],"Perimodiolar array",[55],{"name":56,"affiliation":5,"role":57},"Hans GXM Thomeer, MD, PhD","PRINCIPAL_INVESTIGATOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":47,"email":63},"Imogen AML van Beurden, MD","CONTACT","+31887555555","i.a.m.l.vanbeurden-5@umcutrecht.nl",[65],{"facility":66,"status":67,"city":68,"state":47,"zip":47,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"University Medical Center Utrecht","RECRUITING","Utrecht","Netherlands","NL",{"type":72,"coordinates":73},"Point",[74,75],5.12222,52.09083,{"lat":75,"lon":74},[78,81,82,83,85],{"name":56,"role":61,"phone":79,"phoneExt":47,"email":80},"+310887555555","h.g.x.m.thomeer@umcutrecht.nl",{"name":47,"role":61,"phone":47,"phoneExt":47,"email":63},{"name":56,"role":57,"phone":47,"phoneExt":47,"email":47},{"name":60,"role":84,"phone":47,"phoneExt":47,"email":47},"SUB_INVESTIGATOR",{"name":86,"role":84,"phone":47,"phoneExt":47,"email":47},"Huib Versnel, PhD",{"type":57,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Prof Dr HGXM Thomeer MD PhD","MD PhD","100604232","hearing-preservation-in-cochlear-implantation-surgery-100604232",false,"NCT07146841","Hearing Preservation in Cochlear Implantation Surgery","Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial","CIPRES","Inclusion Criteria:\n\n* Severe hearing loss, CI candidate\n* 18 years of age or older\n* normal function of middle ear (i.e. no acute middle ear infections)\n* dutch language proficiency\n* choice for Advanced Bionics implant\n\nExclusion Criteria:\n\n* prior otologic surgery in the implanted ear (excluding tympanostomy tube placement)\n* inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation)\n* retrocochlear pathology present in the auditory system to be implanted\n* neurocognitive disorders\n* sudden deafness","ALL","18 Years",{"count":101,"type":102},48,"ESTIMATED","INTERVENTIONAL",[105],"NA","In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a \\*straight\\* lateral wall lying electrode array (LW), or a \\*pre-curved\\* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.",[108],"Sensorineural Hearing Loss",[108,110,111,112],"Cochlear Implantation","Residual Hearing Preservation","Electrocochleography","2025-08-21",{"date":115,"type":116},"2025-08-28","ACTUAL",{"date":118,"type":116},"2020-01-29",{"date":120,"type":102},"2027-01-01",{"name":5,"class":6},1]