Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT04057235
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2019-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lkamer@integrityimplants.com', 'phone': '+1.561.529.3861', 'title': 'Lauren Kamer, Senior Director of Regulatory and Clinical Affairs', 'organization': 'Integrity Implants Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a retrospective study of patient chart data. No data was prospectively collected as part of this study. Therefore, follow-up data is limited among the overall cohort.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected at the time of surgery (intraoperative adverse events) and through last patient follow-up, with an average follow-up time of 8.0 ± 4.9 months (range: 0.5-20.5 mo).', 'description': 'Adverse Events were not monitored/assessed with regard to specific Adverse Event Terms.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Retrospective Study Arm', 'description': 'Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 19, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Mild to Moderate Adverse Events', 'notes': 'Other mild to moderate adverse events commonly associated with lumbar interbody fusion surgery. Adverse Events were not monitored/assessed with regard to specific Adverse Event Terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Subsequent surgical intervention', 'notes': 'Revision surgery for failed supplemental instrumentation (pedicle screws or rods; not FlareHawk device) or adjacent segment disease. Adverse Events were not monitored/assessed with regard to specific Adverse Event Terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiographic Arthrodesis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Retrospective Study Arm', 'description': 'Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months +/- 3 months', 'description': 'Proportion of participants with radiographic arthrodesis at 12 months +/- 3 months as determined using plain radiographic images with assessment based on the Bridwell-Lenke grading system \\[Bridwell and Lenke et al, 1995\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had radiographs available at 12 months follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Retrospective Study Arm', 'description': 'Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo)', 'description': 'Visual analog scale for measuring pain intensity related to leg pain. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had VAS Leg data available at both baseline and follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Retrospective Study Arm', 'description': 'Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo)', 'description': 'Visual analog scale for measuring pain intensity related to back pain. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had VAS Back data at both baseline and follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Retrospective Study Arm', 'description': 'Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.6', 'spread': '19.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo)', 'description': 'ODI is used to quantify disability related to lower back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with both baseline and follow-up ODI data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Retrospective Study Arm', 'description': 'Participants who previously underwent Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) surgery with the FlareHawk® expandable interbody fusion device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'Had Radiographic Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'Had ODI Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Had VAS Back Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'Had VAS Leg Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'All 129 participants had data for at least one of the primary/secondary outcomes or adverse events', 'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Retrospective Study Arm', 'description': 'Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.5', 'spread': '12.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Gender of one subject not recorded in patient chart'}, {'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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.3', 'spread': '7.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Non-smoker', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Active smoker', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Previous smoker', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Smoking status not available for 4 patients'}, {'title': 'Co-Morbidities', 'classes': [{'title': 'Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Obesity (BMI >= 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': 'Hypercholesterolemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Coronary Heart Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Hypothyroidism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Active or History of Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline VAS Leg Pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '2.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Visual Analog Scale for Leg Pain; Scale = 0-10; 0 = No Pain; 10 = Worst Pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline VAS Leg Pain score was not recorded in patient chart for some subjects'}, {'title': 'Baseline VAS Back Pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '2.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Visual Analog Scale for Back Pain; Scale = 0-10; 0 = No Pain; 10 = Worst Pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline VAS Back Pain score was not recorded in patient chart for some subjects'}, {'title': 'Baseline ODI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55.0', 'spread': '17.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Oswestry Disability Index; Scale = 0-100\n\n0-20: Minimal disability 21-40: Moderate Disability 41-60: Severe Disability 61-80: Crippling back pain 81-100: Bed-bound', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline ODI score was not recorded in patient chart for some subjects'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-15', 'size': 748310, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-14T11:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-13', 'studyFirstSubmitDate': '2019-08-13', 'resultsFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-01', 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Arthrodesis', 'timeFrame': '12 months +/- 3 months', 'description': 'Proportion of participants with radiographic arthrodesis at 12 months +/- 3 months as determined using plain radiographic images with assessment based on the Bridwell-Lenke grading system \\[Bridwell and Lenke et al, 1995\\].'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up', 'timeFrame': 'From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo)', 'description': 'Visual analog scale for measuring pain intensity related to leg pain. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).'}, {'measure': 'Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up', 'timeFrame': 'From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo)', 'description': 'Visual analog scale for measuring pain intensity related to back pain. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).'}, {'measure': 'Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up', 'timeFrame': 'From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo)', 'description': 'ODI is used to quantify disability related to lower back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'This is a retrospective clinical study (chart review) of patients who have previously undergone Transforaminal Lumbar Interbody Fusion or Posterior Lumbar Interbody Fusion surgery with the FlareHawk expandable interbody fusion cage at one or two contiguous levels.', 'detailedDescription': "The purpose of this study is to evaluate the clinical outcomes of patients who have undergone a Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedure with a FlareHawk expandable interbody fusion cage(s) to assess the device's performance and safety when used in accordance with its intended use. The primary hypothesis is that study subjects who received the FlareHawk expandable cage(s) through a TLIF or PLIF procedure experienced fusion by 12 months (+/- 3 mo) follow-up, with improvements in clinical outcomes related to pain and/or disability compared to pre-operative scores. Further, the subjects are hypothesized to have not experienced any unforeseen device- or procedure-related adverse events."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of at least 100 patients from at least three sites will be enrolled based on inclusion/exclusion criteria. The retrospective chart review will include the full consecutive series of patients who received TLIF or PLIF surgery using the FlareHawk expandable interbody fusion cage between December 1, 2017, and May 31, 2018. Subjects from that consecutive series will be included in the study based on the pre-defined inclusion and exclusion criteria. All subjects will have been diagnosed with degenerative disc disease of the lumbar spine that required lumbar interbody fusion procedure at one or two levels as per the opinion of the treating surgeon. All subjects who meet the inclusion criteria and do not meet any of the exclusion criteria will be included in the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be a part of this study, the subject must:\n\n1. Have been at least 18 years of age and skeletally mature at the time of surgery\n2. Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine\n3. Have been treated with PLIF or TLIF surgery using the FlareHawk expandable interbody cage(s) at 1 or 2 contiguous levels from L2 to S1\n4. Have been treated using the FlareHawk expandable interbody fusion cage, according to the approved labeling, between December 1, 2017, and May 31, 2018\n\nExclusion Criteria:\n\nSubjects must not meet any of the following exclusion criteria to be included in the study:\n\n1. Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s)\n2. Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure\n3. Have had surgery with the FlareHawk device(s) at more than 2 levels\n4. Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1\n5. Have been treated with any bone grafting material other than autogenous or allogenic bone graft in the FlareHawk device(s) and surrounding disc space\n6. Have any contraindications listed in the approved labeling'}, 'identificationModule': {'nctId': 'NCT04057235', 'briefTitle': 'Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrity Implants Inc.'}, 'officialTitle': 'Transforaminal/Posterior Lumbar Interbody Fusion With the FlareHawk® Expandable Interbody Fusion Device: A Retrospective Chart Review Study', 'orgStudyIdInfo': {'id': 'CP-00001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FlareHawk Interbody Fusion System', 'type': 'DEVICE', 'description': 'Expandable lumbar intervertebral body fusion device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Chatham Orthopaedic Associates', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Neurosurgery & Spine Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44333', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Northeast Ohio Spine Center', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}], 'overallOfficials': [{'name': 'Domagoj Coric, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Neurosurgery & Spine Associates, Charlotte, NC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrity Implants Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}