[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593860":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":52,"collaborators":21,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":21,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":21,"enrollmentInfo":63,"targetDuration":21,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":21,"overallStatus":41,"whyStopped":21,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients scheduled for Cochlear Implantation","EXPERIMENTAL","The experimental arm will enroll patients over the age of 18 undergoing cochlear implantation involving the placement of ECE1 at the approximate location of Arnold's nerve within the ear canal. In the proposed study, a modification to the surgical approach will be done to place ECE1 near Arnold's nerve, while still using a standard electrode array.",[13,14],"Device: Cochlear Implant","Device: Modified Implant Procedure",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Cochlear Implant","Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Modified Implant Procedure","Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.",[9],[27],{"name":28,"affiliation":5,"role":29},"J. Thomas Roland, Jr., MD","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":21,"email":35},"Nicole Capach","CONTACT","646-501-6905","nicole.capach@nyulangone.org",{"name":28,"role":33,"phone":37,"phoneExt":21,"email":38},"1-212-263-0460","j.thomas.rolandjr@nyulangone.org",[40],{"facility":5,"status":41,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":21},"RECRUITING","New York","10016","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.00597,40.71427,{"lat":50,"lon":49},{"type":53,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100593860","extra-cochlear-electrode-placement-at-the-post-auricular-vagus-nerve-in-cochlear-implantation-100593860",false,"NCT07011927","Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation","Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation","Inclusion Criteria:\n\n* will be undergoing surgery for a cochlear implant from Cochlear Americas\n* is willing to participate in the study\n\nExclusion Criteria:\n\n* has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted\n* pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.","ALL","18 Years",{"count":64,"type":65},12,"ESTIMATED","INTERVENTIONAL",[68],"NA","This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.",[71],"Hearing Loss","2026-04-27",{"date":74,"type":75},"2026-05-01","ACTUAL",{"date":77,"type":75},"2025-10-17",{"date":79,"type":65},"2028-07-01",{"name":5,"class":6},1]