Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT04577118
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2020-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The iotaSOFT Insertion System Safety Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lchenier@iotamotion.com', 'phone': '442-325-4171', 'title': 'Laura Chenier', 'organization': 'iotaMotion, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Surgery to 1 month post-operative', 'description': 'Device related AEs and general AEs collected.', 'eventGroups': [{'id': 'EG000', 'title': 'iotaSOFT Insertion System', 'description': 'Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 11, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Resistance with iotaSOFT', 'notes': 'Resistance noted at 20mm with electrode array insertion attempted to 24mm. Intra-operative fluoroscopy showed electrode was coiled in the cochlea. After the tip fold over, per protocol, electrode was removed and inserted manually. Resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'No stimulation with device', 'notes': '. Imaging was re-examined and identified a pre-existing temporal bone fracture crossing the internal auditory canal with scarring of the cochlear nerve (implant side). Subject withdrawn from study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drainage at implant site', 'notes': 'Patient reported drainage at implant site. This is identified risk of cochlear implantation surgery as captured in labeling and literature.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising and dizziness', 'notes': 'Bruising and dizziness reported by patient following surgery. This is identified risk of cochlear implantation surgery as captured in labeling and literature.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CSF Leak', 'notes': 'Investigator used otologic drill for pilot hole for motor platform resulted in small CSF leak. Repaired and stopped with fascia and bone wax intraoperatively. No leak at closure. Surgery completed without further consequence or complications.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'No hospitalization necessary. Was seen by provider on 3-3-21. Recommended vestibular rehab locally. Based on time to onset of reported symptoms (74 days after surgery) it is unlikely this is related to use of the iotaSOFT during implantation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision coming open at CI site as seen at 2-week post-op visit.', 'notes': 'Physician addressed by adding small additional suture. At subsequent visit (activation), healing issue resolved and activation occurred. This is identified risk of cochlear implantation surgery as captured in labeling and literature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'notes': "Tinnitus when pushes on implant site. Patient reported tinnitus prior to surgery and by 1-month visit tinnitus 'better'. This is identified risk of cochlear implantation surgery as captured in labeling and literature.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain at incision', 'notes': 'Pain at incision w/ headache. This is identified risk of cochlear implantation surgery as captured in labeling and literature.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling of face and eye area', 'notes': 'Swelling in face and eye area on side of implant site. This is identified risk of cochlear implantation surgery as captured in labeling and literature. Vastly improved at 2-week follow-up', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial Stim', 'notes': 'Facial stim and poor electrode response. At follow-up appointment (activation) the facial stim resolved with widening the pulse width of signal. Electrodes 11 and 12 still no response as surgeon elected shallow insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Altered mental state', 'notes': 'Altered mental state as reported by daughter to ER doctor. Patient has not returned for follow-up visit due to non-associated medical problems. Ongoing contact being made to clinic to reschedule.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient hospitalization following knee surgery', 'notes': 'Patient hospitalization following knee surgery. Knee pain pre-existing prior to surgery per patient/daughter report (ortho note history in medical file)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'iotaSOFT Insertion System', 'description': 'Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Number of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System and descriptions of reported adverse events. AEs will be summarized by type and number of subjects experiencing an event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects in study'}, {'type': 'SECONDARY', 'title': 'Successful Surgical Use of the iotaSOFT Insertion System During Cochlear Implant Surgery as Measured by a Surgeon Utility Questionnaire. The Questionnaire Will be Used to Calculate the Proportion of Subjects in Which the Device Performed as Intended.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'iotaSOFT Insertion System', 'description': 'Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'The questionnaire will collect device handling data on proportion of subjects in which the device performed as intended, device utility, and ease of use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the study'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Procedural Duration of Time for Insertion of the Electrode Array (Mean, Range)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'iotaSOFT Insertion System', 'description': 'Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'The duration of time it takes for electrode array insertion will be measured', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and study completed subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'iotaSOFT Insertion System', 'description': 'Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Post-procedural x-ray with cochlea view will be obtained to radiographically demonstrate positioning of the electrode.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and completed subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events Reported During the Follow-up Period as Documented by Impedance and Neural Response Telemetry Testing. Adverse Events Will be Categorized by Type and Number of Participants Experiencing an Event.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'iotaSOFT Insertion System', 'description': 'Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Potential risks and benefits of iotaSOFT will be assessed and characterized through data obtained during the post-surgical follow-up period while conducting impedance measurements and neural response telemetry.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and completed subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'iotaSOFT Insertion System', 'description': 'Purpose of this study is to evaluate safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant array.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'iotaSOFT Insertion System', 'description': 'Overall number of baseline participants: 25 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '18 years and older', 'unitOfMeasure': 'Participants', 'populationDescription': '4 subjects withdrawn'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '4 subjects were withdrawn from the study.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '4 patients withdrawn'}], 'populationDescription': 'Cochlear implant candidates 18 years and older at the time of surgery.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-02-19', 'size': 770342, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-01T14:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2020-09-22', 'resultsFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-28', 'studyFirstPostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedural Duration of Time for Insertion of the Electrode Array (Mean, Range)', 'timeFrame': 'Day 0', 'description': 'The duration of time it takes for electrode array insertion will be measured'}, {'measure': 'Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure', 'timeFrame': 'Day 0', 'description': 'Post-procedural x-ray with cochlea view will be obtained to radiographically demonstrate positioning of the electrode.'}, {'measure': 'Adverse Events Reported During the Follow-up Period as Documented by Impedance and Neural Response Telemetry Testing. Adverse Events Will be Categorized by Type and Number of Participants Experiencing an Event.', 'timeFrame': '1 month', 'description': 'Potential risks and benefits of iotaSOFT will be assessed and characterized through data obtained during the post-surgical follow-up period while conducting impedance measurements and neural response telemetry.'}], 'primaryOutcomes': [{'measure': 'Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery', 'timeFrame': 'Day 0', 'description': 'Number of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System and descriptions of reported adverse events. AEs will be summarized by type and number of subjects experiencing an event.'}], 'secondaryOutcomes': [{'measure': 'Successful Surgical Use of the iotaSOFT Insertion System During Cochlear Implant Surgery as Measured by a Surgeon Utility Questionnaire. The Questionnaire Will be Used to Calculate the Proportion of Subjects in Which the Device Performed as Intended.', 'timeFrame': 'Day 0', 'description': 'The questionnaire will collect device handling data on proportion of subjects in which the device performed as intended, device utility, and ease of use.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cochlear Implant']}, 'descriptionModule': {'briefSummary': 'Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.', 'detailedDescription': 'This is a confirmatory study to assess successful peri-procedural use of the iotaSOFT Insertion System and potential adverse events that may be caused by use of the system during cochlear implant surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Candidate for cochlear implantation per indications\n* Age 18 years or older\n\nKey Exclusion Criteria:\n\n* Prior cochlear implantation in ear to be treated\n* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray\n* Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging\n* Deafness due to lesions of the acoustic nerve or central auditory pathway\n* Diagnosis of auditory neuropathy\n* Active middle ear infection'}, 'identificationModule': {'nctId': 'NCT04577118', 'briefTitle': 'The iotaSOFT Insertion System Safety Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'iotaMotion, Inc.'}, 'officialTitle': 'The iotaSOFT Insertion System Safety Study', 'orgStudyIdInfo': {'id': 'iotaSOFT000001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'iotaSOFT Insertion System', 'description': 'The iotaSOFT Insertion System is a surgical device that aids the surgeon in implanting cochlear electrode arrays by controlling the speed and distance of implant insertion. All subjects enrolled in the trial will have the iotaSOFT Insertion System used during surgery.', 'interventionNames': ['Device: iotaSOFT Insertion System']}], 'interventions': [{'name': 'iotaSOFT Insertion System', 'type': 'DEVICE', 'description': 'Enrolled subjects undergoing cochlear implant surgery will have the iotaSOFT Insertion System used by the surgeon to assist with implantation of the implant electrode array during the procedure.', 'armGroupLabels': ['iotaSOFT Insertion System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Bruce Gantz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iotaMotion, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}