Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-11 @ 7:24 PM
Study NCT ID:
NCT02335502
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2015-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RDiaz@sjm.com', 'phone': '+19723098601', 'title': 'Roni Diaz', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.', 'eventGroups': [{'id': 'EG000', 'title': 'All Enrolled Subjects', 'description': 'All subjects enrolled into the study with intent to treat with the Axium Neurostimulator', 'otherNumAtRisk': 66, 'otherNumAffected': 7, 'seriousNumAtRisk': 66, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Hematoma (became SAE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Infection (became SAE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Loss of stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Pain at IPG site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Spinal tap headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'seriousEvents': [{'term': 'Dural puncture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hematoma/Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Motor deficit-transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Return of symptoms/worsening of disease state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Intensity for Overall Pain From Pre-treatment Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjected Treated With the Permanent Implantable Axium System', 'description': 'All subjects treated with the Axium implantable neurostimulator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': '3-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.63', 'groupId': 'OG000'}]}]}, {'title': '6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': '12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 6 and 12-Months', 'description': 'The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Differences in participants over time is due to early withdrawals and missing data'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With at Least 50% Pain Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjected Treated With the Permanent Implantable Axium System', 'description': 'All subjects treated with the Axium implantable neurostimulator'}], 'classes': [{'title': '>= 50% Pain Reduction', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': '< 50% Pain Reduction', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and End of Trial Visit', 'description': 'Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects treated with the Axium implantable neurostimulator who completed their end of trial visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Enrolled Subjects', 'description': 'All subjects enrolled into the study with intent to treat with the Axium Neurostimulator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'Received Trial System', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'Receiving Permanent System', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Subjects', 'description': 'All subjects enrolled into the study with intent to treat with the Axium Neurostimulator'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2015-01-07', 'resultsFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-24', 'studyFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Intensity for Overall Pain From Pre-treatment Baseline', 'timeFrame': '3, 6 and 12-Months', 'description': 'The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).'}, {'measure': 'Percentage of Subjects With at Least 50% Pain Reduction', 'timeFrame': 'Baseline and End of Trial Visit', 'description': 'Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': '04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic Pain Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is at least 18 years old\n2. Subject is able and willing to comply with the follow-up schedule and protocol\n3. Chronic, intractable pain in the thoracic, lumbar and/or sacral distribution(s) for at least 6 months\n4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain\n5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain\n6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device\n7. Subject is able to provide written informed consent\n8. Subject speaks Dutch or English\n\nExclusion Criteria:\n\n1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control\n2. Escalating or changing pain condition within the past month as evidenced by investigator examination\n3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days\n4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months\n5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump\n6. Patient has pain only or primarily within a cervical dermatomal distribution\n7. Subject is unable to operate the device\n8. Subjects with indwelling devices that may pose an increased risk of infection\n9. Subjects currently has an active infection\n10. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device\n11. Subject has participated in another clinical investigation within 30 days\n12. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation\n13. Subject has been diagnosed with cancer in the past 2 years'}, 'identificationModule': {'nctId': 'NCT02335502', 'briefTitle': 'A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Intractable Pain', 'orgStudyIdInfo': {'id': '04-SMI-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treated Subjects', 'description': 'All subjects recruited and treated with the Axium neurostimulator', 'interventionNames': ['Device: Implantation with the commercially available Axium neurostimulator']}], 'interventions': [{'name': 'Implantation with the commercially available Axium neurostimulator', 'type': 'DEVICE', 'armGroupLabels': ['Treated Subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC Pijnbehandelcentrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}