Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT02641795
Status:
TERMINATED
Last Update Posted:
2018-10-03
First Post:
2015-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Assisted Cochlear Implantation Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Insufficient enrollment and extended study duration', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2015-12-19', 'studyFirstSubmitQcDate': '2015-12-23', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drilling accuracy', 'timeFrame': 'Image data acquired during the procedure', 'description': 'The lateral distance between the center lines of the planned and drilled tunnel positions at the level of the facial nerve measured from medical image data'}], 'secondaryOutcomes': [{'measure': 'Number of successfully completed robotic procedures', 'timeFrame': 'The procedure (day 0)', 'description': 'The number of procedures drilled robotically to the middle ear cavity'}, {'measure': 'The number of successful cochlear implant electrode array insertions', 'timeFrame': 'The procedure (day 0)', 'description': 'Number of electrode arrays implanted through the key-hole approach to the middle ear cavity'}, {'measure': 'Registration accuracy', 'timeFrame': 'The procedure (day 0)', 'description': 'Fiducial matching error of patient to image registration'}, {'measure': 'Time of the robotic procedure and its subparts', 'timeFrame': 'The procedure (day 0)', 'description': 'Total time of the robotic procedure from opening to closing (mean and standard deviation) and of the subprocesses'}, {'measure': 'Adverse events', 'timeFrame': 'day 0-30', 'description': 'Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc'}, {'measure': 'Blood loss', 'timeFrame': 'The procedure (day 0)', 'description': 'Intraoperative blood loss (ml)'}, {'measure': 'Postoperative pain', 'timeFrame': 'day 0-30', 'description': 'Pain scale and prescribed pain medication'}, {'measure': 'Invasiveness of the intervention', 'timeFrame': 'The procedure (day 0)', 'description': 'Size of incision (mm)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cochlear implantation', 'robotics', 'image guidance'], 'conditions': ['Sensory Hearing Loss']}, 'descriptionModule': {'briefSummary': 'A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.', 'detailedDescription': 'A first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Geographically and physically able to attend scheduled evaluations and follow-up appointments\n* Indicated for cochlear implantation\n* Age 18 years or older\n* Fluent in German or French\n* Sufficient facial recess size ( \\> 2.5 mm between the facial nerve and chorda tympani)\n\nExclusion Criteria:\n\n* Pregnancy\n* Anatomical malformation of the middle or inner ear or unusual facial nerve course\n* Lack of compliance with any inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02641795', 'acronym': 'MIRACI', 'briefTitle': 'Robotic Assisted Cochlear Implantation Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Robotic Assisted Cochlear Implantation Feasibility Study', 'orgStudyIdInfo': {'id': 'CIV-13-12-011779'}, 'secondaryIdInfos': [{'id': 'PB_2017-0031', 'type': 'OTHER', 'domain': 'Ethics commision Bern, Switzerland'}, {'id': '2013-MD-0042', 'type': 'OTHER', 'domain': 'Swissmedic (regulatory authority)'}, {'id': 'CIV-13-12-011779', 'type': 'OTHER', 'domain': 'EUDAMED'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Minimally invasive robotic cochlear implantation with custom device', 'interventionNames': ['Device: Minimally invasive robotic cochlear implantation']}], 'interventions': [{'name': 'Minimally invasive robotic cochlear implantation', 'type': 'DEVICE', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3008', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Marco Caversaccio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}