Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT03689920
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2018-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combining Mechanisms for Better Outcomes (COMBO)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062187', 'term': 'Spinal Cord Stimulation'}, {'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'roshini.jain@bsci.com', 'phone': '661-949-4350', 'title': 'Director of Clinical Sciences', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected up to end of randomized phase (3 months post-randomization)', 'description': 'Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)', 'eventGroups': [{'id': 'EG000', 'title': 'WaveWriter Settings', 'description': 'WaveWriter Programming\n\nBoston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Conventional Settings', 'description': 'Conventional Programming\n\nBoston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Pain Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WaveWriter Settings', 'description': 'WaveWriter Programming\n\nBoston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.'}, {'id': 'OG001', 'title': 'Conventional Settings', 'description': 'Conventional Programming\n\nBoston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post-randomization', 'description': 'Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WaveWriter Settings', 'description': 'WaveWriter Programming\n\nBoston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.'}, {'id': 'FG001', 'title': 'Conventional Settings', 'description': 'Conventional Programming\n\nBoston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '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': '47', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'WaveWriter Settings', 'description': 'WaveWriter Programming\n\nBoston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.'}, {'id': 'BG001', 'title': 'Conventional Settings', 'description': 'Conventional Programming\n\nBoston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '12.23', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '12.09', 'groupId': 'BG001'}, {'value': '57.1', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black, of African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-31', 'size': 6498077, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-04T20:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-28', 'studyFirstSubmitDate': '2018-09-27', 'resultsFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-04', 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Pain Responder Rate', 'timeFrame': '3 months post-randomization', 'description': 'Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Back Pain']}, 'referencesModule': {'references': [{'pmid': '36866658', 'type': 'DERIVED', 'citation': 'Wallace MS, North JM, Phillips GM, Calodney AK, Scowcroft JA, Popat-Lewis BU, Lee JM, Washabaugh EP 3rd, Paez J, Bolash RB, Noles J, Atallah J, Shah B, Ahadian FM, Trainor DM, Chen L, Jain R. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023 Mar;13(3):171-184. doi: 10.2217/pmt-2022-0101. Epub 2023 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.', 'detailedDescription': 'To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.\n* 22 years of age or older at time of enrollment\n* Able to independently read and complete all questionnaires and assessments provided in English\n* Signed a valid, IRB-approved informed consent form (ICF) provided in English\n\nKey Exclusion Criteria:\n\n* Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes\n* Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study\n* Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception\n* Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study"}, 'identificationModule': {'nctId': 'NCT03689920', 'acronym': 'COMBO', 'briefTitle': 'Combining Mechanisms for Better Outcomes (COMBO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Study to Demonstrate the Value of Multiple Modalities and Combining Mechanisms Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain', 'orgStudyIdInfo': {'id': 'A4070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'WaveWriter Settings', 'description': 'WaveWriter Programming', 'interventionNames': ['Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Settings', 'description': 'Conventional Programming', 'interventionNames': ['Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System']}], 'interventions': [{'name': 'Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System', 'type': 'DEVICE', 'description': 'The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.', 'armGroupLabels': ['Conventional Settings', 'WaveWriter Settings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for Pain and Supportive Care', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center - Jacobs Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Back Pain Specialists', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '34711', 'city': 'Clermont', 'state': 'Florida', 'country': 'United States', 'facility': 'South Lake Pain Institute, Inc', 'geoPoint': {'lat': 28.54944, 'lon': -81.77285}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Willis-Knighton River Cities Clinical Research Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Pain Consultants', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48198', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Forest Health Medical Center', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '64086', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': 'KC Pain Centers', 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Research Institute, LLC', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Clinic', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pacific Sports and Spine, LLC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Spine Care', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'EvergreenHealth Pain Care', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}], 'overallOfficials': [{'name': 'Mark Wallace, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}