Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT02896361
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Burst Optimized Stimulation Study
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': 'filippo.agnesi@abbott.com', 'phone': '972-526-4860', 'title': 'Filippo Agnesi, PhD', 'organization': 'Abbott Neuromodulation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Burst', 'description': 'reporting "per intervention" adverse events experienced while standard continuous burst was delivered', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Burst Microdosing 1', 'description': 'reporting "per intervention" adverse events experienced while burst microdosing 1 was delivered', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Burst Microdosing 2', 'description': 'reporting "per intervention" adverse events experienced while burst microdosing 2 was delivered', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bilateral ISG syndrome', 'notes': 'One subject reported an adverse event 35 days after randomization to Group 2. The subject developed a new pain condition, bilateral ISG syndrome after enrollment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing A(5:5)', 'description': 'Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation'}, {'id': 'OG001', 'title': 'Microdosing B: 5:10', 'description': 'Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation'}, {'id': 'OG002', 'title': 'Continuous', 'description': 'Continuously delivered burst SCS'}], 'classes': [{'categories': [{'measurements': [{'value': '46.88', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '48.60', 'spread': '21.48', 'groupId': 'OG001'}, {'value': '46.76', 'spread': '21.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessed every 2 weeks after each intervention, for a total of 6 weeks', 'description': 'Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing A(5:5)', 'description': 'Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation'}, {'id': 'OG001', 'title': 'Microdosing B: 5:10', 'description': 'Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation'}, {'id': 'OG002', 'title': 'Continuous', 'description': 'Continuously delivered burst SCS'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessed every 2 weeks after each intervention, for a total of 6 weeks', 'description': 'European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stimulation Order 1', 'description': 'Stimulations delivered in following order:\n\n1. Standard burst for 2 weeks\n2. Burst Microdosing 1 for 2 weeks\n3. Burst Microdosing 2 for 2 weeks'}, {'id': 'OG001', 'title': 'Stimulation Order 2', 'description': 'Stimulations delivered in following order:\n\n1. Burst Microdosing 1 for 2 weeks\n2. Burst Microdosing 2 for 2 weeks\n3. Standard burst for 2 weeks'}, {'id': 'OG002', 'title': 'Stimulation Order 3', 'description': 'timulations delivered in following order:\n\n1. Burst Microdosing 2 for 2 weeks\n2. Standard burst for 2 weeks\n3. Burst Microdosing 1 for 2 weeks'}], 'classes': [{'categories': [{'title': 'first intervention', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'second intervention', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'third intervention', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'no preference', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assessed 6 weeks after baseline at the last follow up visit', 'description': 'questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were\n\n* first intervention\n* second intervention\n* third intervention\n* no preference', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing A(5:5)', 'description': 'Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation'}, {'id': 'OG001', 'title': 'Microdosing B: 5:10', 'description': 'Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation'}, {'id': 'OG002', 'title': 'Continuous', 'description': 'Continuously delivered burst SCS'}], 'classes': [{'categories': [{'title': 'Dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied or dissatisfied', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'satisfied', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'very dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'very satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assessed every 2 weeks after each intervention, for a total of 6 weeks', 'description': 'questionnaire on satisfaction with current therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'Baseline characteristics for all subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'assessed over 6 weeks of study participation', 'unitOfMeasure': 'percentage of patients with AE', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stimulation Order 1', 'description': 'Stimulations delivered in following order:\n\n1. Standard burst for 2 weeks\n2. Burst Microdosing 1 for 2 weeks\n3. Burst Microdosing 2 for 2 weeks\n\nReprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones'}, {'id': 'FG001', 'title': 'Stimulation Order 2', 'description': 'Stimulations delivered in following order:\n\n1. Burst Microdosing 1 for 2 weeks\n2. Burst Microdosing 2 for 2 weeks\n3. Standard burst for 2 weeks\n\nReprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones'}, {'id': 'FG002', 'title': 'Stimulation Order 3', 'description': 'Stimulations delivered in following order:\n\n1. Burst Microdosing 2 for 2 weeks\n2. Standard burst for 2 weeks\n3. Burst Microdosing 1 for 2 weeks\n\nReprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones'}], 'periods': [{'title': 'First Intervention (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'emergenge of several new painful regions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '29 patients were screened for elegibility between july 2016 and may 2017 Dusseldorf (GER) and Wilrijk (BEL)', 'preAssignmentDetails': '27 of the 29 participants received the study intervention. Of those did not receive study intervention, 1 did not meet inclusion/exlusion criteria and 1 was withdrawn for non compliance.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'Baseline characteristics for all subjects'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline information collected from the two patients that exited the study before receiving intervention was included in the basline analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-02', 'size': 1004051, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-03T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2016-09-01', 'resultsFirstSubmitDate': '2018-08-03', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-17', 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) for Pain', 'timeFrame': 'assessed every 2 weeks after each intervention, for a total of 6 weeks', 'description': 'Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain'}], 'secondaryOutcomes': [{'measure': 'EQ-5D', 'timeFrame': 'assessed every 2 weeks after each intervention, for a total of 6 weeks', 'description': 'European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life'}, {'measure': 'Subject Preference', 'timeFrame': 'assessed 6 weeks after baseline at the last follow up visit', 'description': 'questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were\n\n* first intervention\n* second intervention\n* third intervention\n* no preference'}, {'measure': 'Subject Satisfaction', 'timeFrame': 'assessed every 2 weeks after each intervention, for a total of 6 weeks', 'description': 'questionnaire on satisfaction with current therapy'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'assessed over 6 weeks of study participation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.', 'detailedDescription': 'This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.\n\nSubjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;\n* Subject has been exclusively using burst stimulation for at least three months;\n* Subject is 18 years of age or older;\n* Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;\n* Subject agrees not to add or increase pain-related medication from enrollment through the study duration;\n* Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;\n\nExclusion Criteria:\n\n* Subject is currently participating in a clinical investigation study that includes an active treatment arm;\n* Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;\n* Subject has a non SJM neuromodulation device"}, 'identificationModule': {'nctId': 'NCT02896361', 'acronym': 'BOSS', 'briefTitle': 'Burst Optimized Stimulation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Burst Optimized Stimulation Study', 'orgStudyIdInfo': {'id': 'SJM-CIP-10125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stimulation order 1', 'description': 'Stimulations delivered in following order:\n\n1. Standard burst\n2. Burst Microdosing 1\n3. Burst Microdosing 2', 'interventionNames': ['Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Stimulation order 2', 'description': 'Stimulations delivered in following order:\n\n1. Burst Microdosing 1\n2. Burst Microdosing 2\n3. Standard burst', 'interventionNames': ['Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Stimulation order 3', 'description': 'Stimulations delivered in following order:\n\n1. Burst Microdosing 2\n2. Standard burst\n3. Burst Microdosing 1', 'interventionNames': ['Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol']}], 'interventions': [{'name': 'Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol', 'type': 'DEVICE', 'description': 'Stimulation parameters are reprogrammed from original values to study defined ones', 'armGroupLabels': ['Stimulation order 1', 'Stimulation order 2', 'Stimulation order 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2610', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'NKO Sint-Augustinus', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '47055', 'city': 'Duisburg', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinikum Duisburg GmbH', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Medizinische Einrichtungen der Universität Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Lalit Venkatesan, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Medical Devices'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medizinische Einrichtungen der Universität Düsseldorf', 'class': 'UNKNOWN'}, {'name': 'Klinikum Duisburg GmbH', 'class': 'UNKNOWN'}, {'name': 'NKO Sint-Augustinus Antwerpen', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}