Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 5:03 AM
Study NCT ID:
NCT05079867
Status:
UNKNOWN
Last Update Posted:
2021-10-15
First Post:
2021-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019929', 'term': 'Cochlear Implantation'}], 'ancestors': [{'id': 'D013506', 'term': 'Otologic Surgical Procedures'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-03', 'studyFirstSubmitDate': '2021-10-03', 'studyFirstSubmitQcDate': '2021-10-03', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of cochlear microphonics', 'timeFrame': '0-12 months', 'description': 'Postoperative amplitude of cochlear microphonics'}], 'secondaryOutcomes': [{'measure': 'Cochlear implant impedance', 'timeFrame': '0-12 months', 'description': 'Postoperative value of cochlear implant impedance'}, {'measure': 'Residual hearing', 'timeFrame': '0-12 months', 'description': 'Average audiometric threshold'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss', 'Cochlear Implant', 'Cochlear Microphonics', 'Electrocochleography']}, 'descriptionModule': {'briefSummary': 'Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.', 'detailedDescription': 'Branches:\n\n* Perimodiolar (PM)\n* Lateral wall (PL)\n\nFollow up schedule:\n\nPreoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 12 months of age who will receive a cochlear implant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz\n\nExclusion Criteria:\n\nMedical or pharmacological comorbid condition that contraindicates cochlear implantation.\n\nPrevious implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol.\n\nSurgical impossibility to follow the guidelines of the minimally traumatic technique.'}, 'identificationModule': {'nctId': 'NCT05079867', 'briefTitle': 'Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes', 'orgStudyIdInfo': {'id': '5906'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Perimodiolar (PM)', 'description': 'Patients to be implanted with: Mid Scala or CI532 / 632 (Slim modiolar) electrode', 'interventionNames': ['Device: Cochlear implantation']}, {'label': 'Lateral wall (PL)', 'description': 'Patients to be implanted with: Slim J or CI522 / 622 (Slim Lateral) electrode', 'interventionNames': ['Device: Cochlear implantation']}], 'interventions': [{'name': 'Cochlear implantation', 'type': 'DEVICE', 'description': "Electrode surgically implanted in patient's cochlea to improve hearing", 'armGroupLabels': ['Lateral wall (PL)', 'Perimodiolar (PM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1199ABB', 'city': 'Capital Federal', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Federico A Di Lella, MD PhD', 'role': 'CONTACT', 'email': 'federico.dilella@hospitalitaliano.org.ar', 'phone': '54-11-49590200', 'phoneExt': '9490'}], 'facility': 'Hospital Italiano de Buenos Aires'}], 'centralContacts': [{'name': 'Federico A Di Lella, MD PhD', 'role': 'CONTACT', 'email': 'federico.dilella@hospitalitaliano.org.ar', 'phone': '+5411 49590200', 'phoneExt': '9490'}], 'overallOfficials': [{'name': 'Federico A Di Lella, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'FEDERICO ALBERTO DI LELLA', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}