Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02093793
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2014-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001416', 'term': 'Back 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': 'roshini.jain@bsci.com', 'phone': '6619494350', 'title': 'Director of Clinical Sciences', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were collected through end of crossover phase (High Rate SCS followed by Commercial SCS or vice versa group) or up to 3 months post activation (HR settings only group) for subjects who started the study (n = 256)', 'description': 'All adverse events were collected through end of crossover phase (High Rate SCS followed by Commercial SCS or vice versa group) or up to 3 months post activation (HR settings only group) for subjects who started the study (n = 256)', 'eventGroups': [{'id': 'EG000', 'title': 'High Rate SCS', 'description': 'High Rate SCS Settings', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 11, 'seriousNumAtRisk': 188, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Commercial SCS', 'description': 'Commercial SCS Settings', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 13, 'seriousNumAtRisk': 188, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'High Rate Settings Only', 'description': 'High Rate settings only', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 4, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Implant Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pnuemonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral Heamorhhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sick Sinus Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroentritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Implant Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Commercial SCS', 'description': 'Commercial SCS (as part of crossover)'}, {'id': 'OG001', 'title': 'High Rate SCS', 'description': 'High Rate SCS (as part of crossover)'}, {'id': 'OG002', 'title': 'High Rate Settings Only', 'description': 'High Rate settings only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000'}, {'value': '0.53', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months post-activation', 'description': "Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate).\n\nA comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS", 'unitOfMeasure': 'probability', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with a successful trial (High rate settings only) or simulated trial responders (High rate SCS followed by Commercial SCS or vice versa)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Rate SCS Followed by Commercial SCS', 'description': 'High Rate SCS Settings followed by Commercial Settings'}, {'id': 'FG001', 'title': 'Commercial SCS Settings Followed by High Rate SCS', 'description': 'Commercial SCS Settings followed by High Rate SCS programming settings'}, {'id': 'FG002', 'title': 'High Rate Settings Only', 'description': 'High Rate settings only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High Rate SCS Followed by Commercial SCS', 'description': 'High Rate SCS Settings followed by Commercial Settings'}, {'id': 'BG001', 'title': 'Commercial SCS Settings Followed by High Rate SCS', 'description': 'Commercial SCS Settings followed by High Rate SCS programming settings'}, {'id': 'BG002', 'title': 'High Rate Settings Only', 'description': 'High Rate settings only'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '53.6', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '58.5', 'spread': '11.4', 'groupId': 'BG002'}, {'value': '55.6', 'spread': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '216', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-06', 'size': 20056280, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-02T23:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2014-03-19', 'resultsFirstSubmitDate': '2019-12-23', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-29', 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates', 'timeFrame': '3 months post-activation', 'description': "Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate).\n\nA comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Back Pain']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain', 'detailedDescription': 'To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.\n* Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician\n* Be 22 years of age or older at the time of enrollment\n* Be willing and capable of giving informed consent\n* Be willing and able to comply with study-related requirements, procedures, and visits\n\nExclusion Criteria:\n\n* Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator\n* Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist\n* Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)\n* Have a current systemic infection, or local infection in close proximity to anticipated surgical field\n* Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.\n* Be participating in another clinical study that may influence the data collected for the study'}, 'identificationModule': {'nctId': 'NCT02093793', 'acronym': 'ACCELERATE', 'briefTitle': 'Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation', 'orgStudyIdInfo': {'id': 'A4007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Rate Spinal Cord Stimulation', 'description': 'PRECISION SCS Adapted for High-Rate SCS', 'interventionNames': ['Device: PRECISION SCS Adapted for High-Rate SCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial Rate Spinal Cord Stimulation', 'description': 'PRECISION SCS Adapted for High-Rate SCS', 'interventionNames': ['Device: PRECISION SCS Adapted for High-Rate SCS']}], 'interventions': [{'name': 'PRECISION SCS Adapted for High-Rate SCS', 'type': 'DEVICE', 'otherNames': ['Boston Scientific PRECISION Spinal Cord Stimulator System'], 'description': 'Comparison of spinal cord stimulation parameters', 'armGroupLabels': ['Commercial Rate Spinal Cord Stimulation', 'High Rate Spinal Cord Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92009', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Coastal Pain & Spinal Diagnostics', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center - 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