protocolSection identificationModule nctId: NCT06268340, orgStudyIdInfo id: ABIntl-23-25, briefTitle: Hearing and Structure Preservation Via ECochG, acronym: PRESERVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Advanced Bionics AG, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Hearing Loss, Sensorineural, conditions: Severe-to-profound Hearing Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: ECochG monitored CI surgery incl. corrective action guide, interventions name: Routine CI surgery without ECochG monitoring, outcomesModule primaryOutcomes measure: Hearing Preservation, secondaryOutcomes measure: Structure Preservation, secondaryOutcomes measure: Speech perception, otherOutcomes measure: Surgeons' feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitair Ziekenhuis Gent, city: Gent, zip: 9000, country: Belgium, contacts name: Lara Derycke, Ms, role: CONTACT, phone: +3293321246, email: Lara.derycke@ugent.be, contacts name: Ingeborg Dhooge, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Freya Swinnen, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: Le Centre Hospitalier Régional Universitaire de Tours, city: Tours, zip: 37000, country: France, contacts name: Mme Nollet, role: CONTACT, email: promotions.externes@chu-tours.fr, contacts name: David Bakhos, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Mathieu Robier, Mr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Universitätsklinikum Freiburg Klinik, city: Freiburg, zip: 79106, country: Germany, contacts name: Claudia Greulich, Ms, role: CONTACT, email: claudia.greulich@uniklinik-freiburg.de, contacts name: Antje Aschendorff, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Thomas Wesarg, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.9959, lon: 7.85222, locations facility: Ospedale Martini, city: Torino, state: TO, zip: 10141, country: Italy, contacts name: Diego Di Lisi, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Patrizia Consolino, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, locations facility: World Hearing Center, city: Warsaw, state: Nadarzyn, zip: 05-830, country: Poland, contacts name: Iwona Tomaszewska-Hert, Ms, role: CONTACT, email: i.tomaszewska@csim.home.pl, contacts name: Piotr Skarżyński, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Adam Walkowiak, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Cambridge University Hospitals NHS Foundation Trust, city: Cambridge, state: England, zip: CB2 0QQ, country: United Kingdom, contacts name: Sophie McKenny, Ms, role: CONTACT, phone: +441223586625, email: sophie.mckenny@nhs.net, contacts name: Matthew E Smith, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Patrick Axon, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.2, lon: 0.11667, hasResults: False