Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 5:48 AM
Study NCT ID:
NCT04563793
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BSNClinicalTrials@bsci.com', 'phone': '855-213-9890', 'title': 'Sr. Director, Clinical Operations', 'organization': 'Boston Scientific Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.', 'description': 'Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study.\n\nAll Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.', 'eventGroups': [{'id': 'EG000', 'title': 'Superion™ IDS', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.\n\nSuperion™ IDS: All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 3, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Purulent discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Incision site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Spinal Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep Vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Low Back Pain Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Superion™ IDS 6-Month Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.'}, {'id': 'OG001', 'title': 'Superion™ IDS 1-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.'}, {'id': 'OG002', 'title': 'Superion™ IDS 2-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 2-Year Visit.'}, {'id': 'OG003', 'title': 'Superion™ IDS 3-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years post-procedure', 'description': 'Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).\n\nPatients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.'}, {'type': 'PRIMARY', 'title': 'Left Leg Pain Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Superion™ IDS 6-Month Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.'}, {'id': 'OG001', 'title': 'Superion™ IDS 1-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.'}, {'id': 'OG002', 'title': 'Superion™ IDS 2-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 2-Year Visit.'}, {'id': 'OG003', 'title': 'Superion™ IDS 3-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years post-procedure', 'description': 'Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).\n\nPatients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.'}, {'type': 'PRIMARY', 'title': 'Right Leg Pain Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Superion™ IDS 6-Month Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.'}, {'id': 'OG001', 'title': 'Superion™ IDS 1-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.'}, {'id': 'OG002', 'title': 'Superion™ IDS 2-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 2-Year Visit.'}, {'id': 'OG003', 'title': 'Superion™ IDS 3-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years post-procedure', 'description': 'Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).\n\nPatients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Low Back Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Superion™ IDS 6-Month Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.'}, {'id': 'OG001', 'title': 'Superion™ IDS 1-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '42.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 years post-procedure', 'description': "Percent Low Back Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR).\n\nPPR is a questionnaire assessing how much of the subject's low back pain has been relieved by treatment. Pain relief is expressed as a percentage from 0 - 100%.", 'unitOfMeasure': 'percentage of low back pain relief', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients completed the percent pain relief at 2 and 3-Year Follow-up Visits. Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).\n\nPatients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life (QoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Superion™ IDS 6-Month Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.'}, {'id': 'OG001', 'title': 'Superion™ IDS 1-Year Follow-up', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '89.2', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '44.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 years post-procedure', 'description': "Percent of change from Baseline index score to the Follow-up timepoints index score using EQ-5D-5L.\n\nEuroQol Five Dimensions Five Level questionnaire (EQ-5D-5L) is comprised of a descriptive system and a visual analog scale (VAS). The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. VAS is used to record the subject's self-rated health on a 20cm vertical line with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. To calculate the Index Value, responses are converted into a single score using a specific algorithm. Score ranges from 0.000 (representing death) to 1.000 (representing perfect health). The algorithm is based on public preferences, reflecting how different health states are valued by the general public.", 'unitOfMeasure': 'percent change of score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients completed EQ5D-5L at 2 and 3 year visits. Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).\n\nPatients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Superion™ IDS', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.\n\nSuperion™ IDS: All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.\n\nPatients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Superion™ IDS', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.\n\nSuperion™ IDS: All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '8.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'American Indian or Alaska native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black, of African heritage', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Caucasian', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not disclosed', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Low Back pain/symptoms', 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Percentage of patients with low back pain/symptoms', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects who completed the baseline information. Two subjects were consented but did not complete the baseline information.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-02', 'size': 6176239, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-15T13:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2020-09-17', 'resultsFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-22', 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent Low Back Pain Relief', 'timeFrame': 'Up to 3 years post-procedure', 'description': "Percent Low Back Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR).\n\nPPR is a questionnaire assessing how much of the subject's low back pain has been relieved by treatment. Pain relief is expressed as a percentage from 0 - 100%."}, {'measure': 'Quality of Life (QoL)', 'timeFrame': 'Up to 3 years post-procedure', 'description': "Percent of change from Baseline index score to the Follow-up timepoints index score using EQ-5D-5L.\n\nEuroQol Five Dimensions Five Level questionnaire (EQ-5D-5L) is comprised of a descriptive system and a visual analog scale (VAS). The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. VAS is used to record the subject's self-rated health on a 20cm vertical line with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. To calculate the Index Value, responses are converted into a single score using a specific algorithm. Score ranges from 0.000 (representing death) to 1.000 (representing perfect health). The algorithm is based on public preferences, reflecting how different health states are valued by the general public."}], 'primaryOutcomes': [{'measure': 'Low Back Pain Responder Rate', 'timeFrame': 'Up to 3 years post-procedure', 'description': 'Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)'}, {'measure': 'Left Leg Pain Responder Rate', 'timeFrame': 'Up to 3 years post-procedure', 'description': 'Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)'}, {'measure': 'Right Leg Pain Responder Rate', 'timeFrame': 'Up to 3 years post-procedure', 'description': 'Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lumbar Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'To compile real-world outcomes of the Superion™ IDS in routine clinical practice.', 'detailedDescription': 'The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with moderate Lumbar Spinal Stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)\n* Signed a valid, IRB approved informed consent form\n\nKey Exclusion Criteria:\n\n* Meets any contraindication in BSC Indirect Decompression Systems local IFU'}, 'identificationModule': {'nctId': 'NCT04563793', 'acronym': 'PRESS2', 'briefTitle': 'Postmarket Outcomes Study for Evaluation of the Superion™ Spacer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Postmarket Outcomes Study for Evaluation of the Superion™ Spacer', 'orgStudyIdInfo': {'id': 'A4086'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Superion™ IDS', 'description': 'All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.', 'interventionNames': ['Device: Superion™ IDS']}], 'interventions': [{'name': 'Superion™ IDS', 'type': 'DEVICE', 'description': 'All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.', 'armGroupLabels': ['Superion™ IDS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Pain Medicine Associates', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '94939', 'city': 'Larkspur', 'state': 'California', 'country': 'United States', 'facility': 'California Orthopedics & Spine', 'geoPoint': {'lat': 37.93409, 'lon': -122.53525}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Relieve Pain Center, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Source Healthcare', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Institute', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'IPM Medical Group Inc', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital Inc.', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33477', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Louis J. Raso, MD, PA', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '32953', 'city': 'Merritt Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Pain Institute', 'geoPoint': {'lat': 28.359, 'lon': -80.69}}, {'zip': '33948', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Southwest Florida Pain Center', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '30265', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Pain and Spine Care, Inc.', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '31501', 'city': 'Waycross', 'state': 'Georgia', 'country': 'United States', 'facility': 'Centurion Spine and Pain Centers', 'geoPoint': {'lat': 31.21368, 'lon': -82.3557}}, {'zip': '83854', 'city': 'Post Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'North Idaho Day Surgery LLC', 'geoPoint': {'lat': 47.71796, 'lon': -116.95159}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '64086', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': 'KC Pain Centers', 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive and Interventional Pain Management LLP', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '07702', 'city': 'Shrewsbury', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Premier Pain Center', 'geoPoint': {'lat': 40.32955, 'lon': -74.06153}}, {'zip': '08873', 'city': 'Somerset', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Clinical Research Center', 'geoPoint': {'lat': 40.4976, 'lon': -74.48849}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Toledo Clinic', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center for Interventional Pain and Spine', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '78041', 'city': 'Laredo', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Spine Pain Solution', 'geoPoint': {'lat': 27.50641, 'lon': -99.50754}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Spine Care', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Natalie Bloom Lyons', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}