Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT02905305
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cochlear Implant With Anti-Inflammatory Agent
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical feedback', 'timeFrame': 'During surgery', 'description': 'Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode'}, {'measure': 'Safety of Combined Device', 'timeFrame': 'Monitoring over 24 months', 'description': 'Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device'}], 'secondaryOutcomes': [{'measure': 'Electrode impedance', 'timeFrame': 'Testing over 24 months'}, {'measure': 'Electrically evoked compound action potential (ECAP)', 'timeFrame': 'Testing over 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cochlear implants', 'Dexamethasone', 'combined device'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device.\n\nIn the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years\n2. Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age\n3. Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)\n\nExclusion Criteria:\n\n1. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including MRI\n2. Current use of grommets or evidence of tympanic membrane perforation\n3. Known allergic reaction to dexamethasone or similar medicine\n4. Diagnosis of Auditory Neuropathy\n5. Active middle ear infection or history of middle ear infection within past two years\n6. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device\n7. Unwillingness or inability of the candidate to comply with all investigational requirements\n8. Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation'}, 'identificationModule': {'nctId': 'NCT02905305', 'briefTitle': 'Cochlear Implant With Anti-Inflammatory Agent', 'organization': {'class': 'OTHER', 'fullName': 'The Hearing Cooperative Research Centre'}, 'officialTitle': 'Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone', 'orgStudyIdInfo': {'id': 'CLTD 5495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CA with dexamethasone base', 'description': 'Contour Advance electrode with controlled dose of dexamethasone base', 'interventionNames': ['Device: Contour Advance electrode with controlled dose of dexamethasone base']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Contour Advance', 'description': 'Standard Contour Advance electrode array', 'interventionNames': ['Device: Contour Advance electrode']}], 'interventions': [{'name': 'Contour Advance electrode with controlled dose of dexamethasone base', 'type': 'DEVICE', 'description': 'The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.', 'armGroupLabels': ['CA with dexamethasone base']}, {'name': 'Contour Advance electrode', 'type': 'DEVICE', 'description': 'Standard Contour Advance electrode', 'armGroupLabels': ['Contour Advance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3053', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The HEARing CRC', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hearing Cooperative Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cochlear', 'class': 'INDUSTRY'}, {'name': 'Royal Victoria Eye and Ear Hospital', 'class': 'OTHER_GOV'}, {'name': 'Royal Prince Alfred Hospital, Sydney, Australia', 'class': 'OTHER'}, {'name': "St Vincent's Hospital Melbourne", 'class': 'OTHER'}, {'name': 'Westmead Hospital, New South Wales', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}