Nctid:
NCT06235073
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000034381", "term"=>"Hearing Loss"}, {"id"=>"D000006319", "term"=>"Hearing Loss, Sensorineural"}], "ancestors"=>[{"id"=>"D000006311", "term"=>"Hearing Disorders"}, {"id"=>"D000004427", "term"=>"Ear Diseases"}, {"id"=>"D000010038", "term"=>"Otorhinolaryngologic Diseases"}, {"id"=>"D000012678", "term"=>"Sensation Disorders"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M24420", "name"=>"Hearing Loss", "asFound"=>"Hearing Loss", "relevance"=>"HIGH"}, {"id"=>"M6840", "name"=>"Deafness", "relevance"=>"LOW"}, {"id"=>"M9407", "name"=>"Hearing Loss, Sensorineural", "asFound"=>"Cochlear Hearing Loss", "relevance"=>"HIGH"}, {"id"=>"M9400", "name"=>"Hearing Disorders", "relevance"=>"LOW"}, {"id"=>"M7601", "name"=>"Ear Diseases", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}, {"id"=>"M15490", "name"=>"Sensation Disorders", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>10}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-07-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-10", "completionDateStruct"=>{"date"=>"2023-09-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2023-10-19", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-09-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Speech disyllabic recognition", "timeFrame"=>"at 1 year"}], "secondaryOutcomes"=>[{"measure"=>"Pure tone average", "timeFrame"=>"At 1 year"}, {"measure"=>"Intrascalar positionning", "timeFrame"=>"Postoperatively"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Cochlear Hearing Loss"]}, "descriptionModule"=>{"briefSummary"=>"Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due to inter-individual variability of preoperative audiometric thresholds and the various possible intrascalar positions of the electrode array. WThe investigators aim to compare the hearing results of patients who underwent bilateral cochlear implantation, one side was performed with manual insertion and the other side with robot-assisted insertion. The electrode array intrascalar positioning and the surgery duration were also studied.\n\nThis retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation. The unique composition of this cohort enabled the investigators to utilize each patient as their own control.", "detailedDescription"=>"Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due to inter-individual variability of preoperative audiometric thresholds and the various possible intrascalar positions of the electrode array. The investigators aim to compare the hearing results of patients who underwent bilateral cochlear implantation, one side was performed with manual insertion and the other side with robot-assisted insertion. The electrode array intrascalar positioning and the surgery duration were also studied.\n\nThis retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation. The unique composition of this cohort enabled the investigators to utilize each patient as their own control."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"73 years", "minimumAge"=>"44 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"This retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation at a tertiary referral center. Manual cochlear implantations were performed between January 2006 and June 2020, while robot-assisted implantations took place between September 2020 and May 2022. Sequential implantation was applied to 9 of the patients, while 1 patient underwent both manual and robot-assisted cochlear implantations in a single procedure.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* bilateral cochlear implantation at a tertiary referral center\n* one side manual\n* one side robot-assisted\n\nExclusion Criteria:\n\n* opposition\n* under curatorship"}, "identificationModule"=>{"nctId"=>"NCT06235073", "acronym"=>"ICRobMan", "briefTitle"=>"Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Brest"}, "officialTitle"=>"Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position", "orgStudyIdInfo"=>{"id"=>"29BRC23.0107 - ICRobMan"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Manual implantation"}, {"label"=>"Robot assisted implantation"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"29609", "city"=>"Brest", "country"=>"France", "facility"=>"Chru de Brest", "geoPoint"=>{"lat"=>48.3903, "lon"=>-4.48628}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"Data will be available beginning three years and ending fifteen years following the final study report completion", "ipdSharing"=>"YES", "description"=>"All collected data that underlie results in a publication", "accessCriteria"=>"Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital, Brest", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
