Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-04-17 @ 2:26 PM
Study NCT ID:
NCT02068768
Status:
TERMINATED
Last Update Posted:
2019-07-05
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
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': 'tammy.stinson2@zimmerbiomet.com', 'phone': '303-501-8571', 'title': 'Clinical Affairs', 'organization': 'Zimmer Biomet Spine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Poor enrollment led to early termination and low number of participants available for analysis'}}, 'adverseEventsModule': {'timeFrame': 'From time of surgery through 12 months post op', 'description': 'All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)', 'eventGroups': [{'id': 'EG000', 'title': 'Operated Subjects', 'description': 'Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1\n\nAvenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fusion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Subjects', 'description': 'Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1\n\nAvenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months after device implantation', 'description': 'Number of participants with fused disc space as measured radiographically', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Poor enrollment led to early termination and low number of participants available for analysis. Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months. Only 3 of 6 participants reaching 12 month follow up had radiographs available for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Oswestry Disability Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Subjects', 'description': 'Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1\n\nAvenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine'}], 'classes': [{'title': 'Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '72'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '57'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '56'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '47'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'preop, 3 mo, 6 mo, 12 mo post op', 'description': 'The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale (VAS) of Back Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Subjects', 'description': 'Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1\n\nAvenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine'}], 'classes': [{'title': 'Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '75'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '67'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'preop, 3 mo, 6 mo, 12 mo', 'description': 'The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either "no pain" or "worst imaginable pain". The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Operated Subjects', 'description': 'Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1\n\nAvenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Early Termination by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Operated Subjects', 'description': 'Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1\n\nAvenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'groupId': 'BG000', 'lowerLimit': '23.2', 'upperLimit': '42.4'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Previous Lumbar Surgery', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgical Level', 'classes': [{'categories': [{'title': 'L2-L3', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'L3-L4', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'L4-L5', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'L2-L4', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects enrolled and completed surgery with implant of Avenue L device'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2014-02-19', 'resultsFirstSubmitDate': '2019-01-18', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-12', 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fusion Rate', 'timeFrame': '12 months after device implantation', 'description': 'Number of participants with fused disc space as measured radiographically'}], 'secondaryOutcomes': [{'measure': 'Mean Oswestry Disability Index (ODI)', 'timeFrame': 'preop, 3 mo, 6 mo, 12 mo post op', 'description': 'The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.'}, {'measure': 'Visual Analog Scale (VAS) of Back Pain', 'timeFrame': 'preop, 3 mo, 6 mo, 12 mo', 'description': 'The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either "no pain" or "worst imaginable pain". The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['fusion', 'lateral interbody fusion system', 'lumbar spine', 'degenerative disc disease'], 'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be drawn from the patient populations of the physicians participating in the study. The principal investigators include community physicians in private practice as well as physicians affiliated with academic institutions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage)\n* Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery\n* Subject should have had a minimum of 6 months of non-operative treatment prior to surgery\n* The placement of the Avenue L device must be a primary surgery\n* Subject must be willing to sign the consent form and be able to return for all follow up visits.\n\nExclusion Criteria:\n\n* Subject must not have had prior surgery at the operative level(s)\n* Subject is known to have substance or alcohol addictions\n* Subject has lateral curvature of the spine (scoliosis, all types)\n* Subject is a prisoner\n* Subject is pregnant\n* Subject has an active infection or sepsis at the time of surgery\n* Subject has any neuromuscular disorder that would preclude accurate neurologic evaluations'}, 'identificationModule': {'nctId': 'NCT02068768', 'briefTitle': 'Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation', 'organization': {'class': 'INDUSTRY', 'fullName': 'LDR Spine USA'}, 'officialTitle': 'A Prospective, Multicenter, Open Label Clinical Study of the Safety andEfficacy of the Avenue L Interbody Spinal Fusion System Using the VerteBRIDGE Plating System and Supplemental Posterior Fixation', 'orgStudyIdInfo': {'id': 'AveL100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operated Subjects', 'description': 'Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1', 'interventionNames': ['Device: Avenue® L Interbody Fusion System (LDR Spine)']}], 'interventions': [{'name': 'Avenue® L Interbody Fusion System (LDR Spine)', 'type': 'DEVICE', 'description': 'PEEK, intervertebral cage for interbody fusion of the lumbar spine', 'armGroupLabels': ['Operated Subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Center for Spine and Orthopedics', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Orthopedic Surgery', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jersey Shore University Medical Center', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'city': 'Johnson City', 'state': 'New York', 'country': 'United States', 'facility': 'Southern New York Neurosurgical Group', 'geoPoint': {'lat': 42.11563, 'lon': -75.95881}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LDR Spine USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}