Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-02-27 @ 8:16 AM
Study NCT ID:
NCT03246061
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2017-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chilker@relievant.com', 'phone': '(650) 368-1000', 'title': 'Chris Hilker, Sr. Director Clinical Affairs', 'organization': 'Relievant Medsystems'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Enrollment through 24 month follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'BVN Ablation', 'description': 'BVN ablation with continued standard care\n\nIntracept System: BVN ablation using radiofrequency energy', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 16, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care Control', 'description': 'Continue with non-surgical standard care\n\nStandard Care: Non-surgical standard care', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 6, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transient Leg Pain', 'notes': 'Temporary leg pain resolved in mean of 42 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'notes': 'Post anesthesia related urinary retention. Resolved with catheterization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incisional Pain', 'notes': 'Post procedure incision region discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ongoing low back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disc Herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incomplete Procedure', 'notes': 'Inability to access', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basivertebral Never (BVN) Ablation', 'description': 'BVN ablation with standard care\n\nIntracept System: RF ablation'}, {'id': 'OG001', 'title': 'Standard Care Control', 'description': 'Continue with standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.3', 'groupId': 'OG000', 'lowerLimit': '-29.6', 'upperLimit': '-21.0'}, {'value': '-4.4', 'groupId': 'OG001', 'lowerLimit': '-8.7', 'upperLimit': '-0.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Interim Analysis p-value for significance of \\<0.025 for an overall alpha of 0.05', 'groupDescription': 'Estimates and p-value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputation. Note: 3 month visit is computed as post-treatment for the RF Ablation Arm, and post-randomization for the Control Arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 months', 'description': 'Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient.\n\nThese data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Interim Analysis N=104 (pre-specified interim analysis when approximately 60% of randomized participants complete their 3-month primary endpoint'}, {'type': 'SECONDARY', 'title': 'Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basivertebral Nerve (BVN) Ablation', 'description': 'BVN ablation with non-surgical standard care\n\nIntracept System: BVN ablation'}, {'id': 'OG001', 'title': 'Standard Care Control', 'description': 'Continue with non-surgical standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.46', 'groupId': 'OG000', 'lowerLimit': '-4.10', 'upperLimit': '-2.82'}, {'value': '-1.02', 'groupId': 'OG001', 'lowerLimit': '-1.66', 'upperLimit': '-0.37'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Estimates and p-value from ANCOVA with a factor of treatment group and a covariate of baseline VAS score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 months post treatment / randomization', 'description': 'Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline.\n\nThese data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Interim Analysis population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Basivertebral Nerve (BVN) Ablation', 'description': 'BVN ablation with non-surgical standard care\n\nIntracept System: BVN ablation'}, {'id': 'FG001', 'title': 'Standard Care Control', 'description': 'Continue with non-surgical standard care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Interim Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Still in follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'preAssignmentDetails': '420 patients screened for MRI Modic changes at levels L3 to S1 to achieve 140 enrollments. Patients with Modic changes at other levels or who had other primary etiologies for their low back pain (i.e. disc herniation, stenosis, facet joint) were excluded. An independent orthopedic surgeon medical reviewer confirmed eligibility prior to randomization. A pre-specified interim analysis was conducted when 60% of randomized patients completed their 3-month primary endpoint visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Basivertebral Nerve (BVN) Ablation', 'description': 'BVN ablation with standard care\n\nIntracept System: BVN ablation'}, {'id': 'BG001', 'title': 'Standard Care Control', 'description': 'Continue standard care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '50.0', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Oswestry Disability Index (ODI)', 'classes': [{'categories': [{'measurements': [{'value': '44.0', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '46.1', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Oswestry Disability Index (ODI) total score is on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Visual Analogue Scale (VAS)', 'classes': [{'categories': [{'measurements': [{'value': '6.51', 'spread': '1.31', 'groupId': 'BG000'}, {'value': '6.82', 'spread': '1.34', 'groupId': 'BG001'}, {'value': '6.67', 'spread': '1.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Low Back Pain Visual Analog Scale (VAS). Participant indicated level of low back pain on a 10 point numeric scale with 0 being no pain and 10 being maximum pain. The published minimal clinically important difference for VAS is a 2 point reduction from baseline value.', 'unitOfMeasure': 'units on a scale of 0 to 10', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-17', 'size': 1066266, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-12T15:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'BVN Ablation vs Standard Care Control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2017-08-08', 'resultsFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-30', 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)', 'timeFrame': '3 months', 'description': 'Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient.\n\nThese data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.'}], 'secondaryOutcomes': [{'measure': 'Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)', 'timeFrame': '3 months post treatment / randomization', 'description': 'Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline.\n\nThese data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://intraceptstudy.com', 'label': 'INTRACEPT Study Website'}]}, 'descriptionModule': {'briefSummary': 'Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment.\n\nThe study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.', 'detailedDescription': 'Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up).\n\nControl arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skeletally mature subjects at least 25 years of age\n* Chronic lower back pain for at least 6 months\n* Failure to respond to at least 6 months of non-operative conservative management\n\nExclusion Criteria:\n\n* Radicular pain\n* Current or history of spinal infection\n* Modic changes at vertebral bodies other than L3 to S1\n* Contraindication to MRI\n* Pregnant, lactating or plan to become pregnant in next year\n* Has life expectancy of less than 2 years\n* Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired'}, 'identificationModule': {'nctId': 'NCT03246061', 'acronym': 'CLBP', 'briefTitle': 'INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Relievant Medsystems, Inc.'}, 'officialTitle': 'INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'CIP 0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BVN Ablation', 'description': 'BVN ablation with continued standard care', 'interventionNames': ['Device: Intracept System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Control', 'description': 'Continue with non-surgical standard care', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Intracept System', 'type': 'DEVICE', 'description': 'BVN ablation using radiofrequency energy', 'armGroupLabels': ['BVN Ablation']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Non-surgical standard care', 'armGroupLabels': ['Standard Care Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85048', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Brain and Spine', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medicine of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Orthopaedic Surgery', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Back Specialists', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Drug Studies America', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St Luke's Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '13326', 'city': 'Cooperstown', 'state': 'New York', 'country': 'United States', 'facility': 'Bassett Medical Center', 'geoPoint': {'lat': 42.70048, 'lon': -74.92426}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '73013', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Clinical Investigations', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pacific Sports and Spine', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19147', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Spine Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Steven R Garfin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Independent'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'End of trial', 'ipdSharing': 'YES', 'description': 'Trial results will be published at the completion of the trial', 'accessCriteria': 'To be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Relievant Medsystems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}