Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT02093520
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2014-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The MiDAS ENCORE Study
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': 'kdavis@vertosmed.com', 'phone': '9493490008', 'title': 'VP of Clinical Affairs', 'organization': 'Vertos Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications', 'eventGroups': [{'id': 'EG000', 'title': 'Minimally Invasive Lumbar Decompression (MILD)', 'description': 'Image guided minimally-invasive lumbar decompression\n\nMinimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 2, 'seriousNumAtRisk': 149, 'deathsNumAffected': 2, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Epidural Steroid Injection (ESI)', 'description': 'An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.\n\nEpidural Steroid Injection: Injection of epidural steroids into the lumbar spine', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 2, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Cardiac disorders', 'notes': 'Procedure related adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injury, poisoning and procedural complications', 'notes': 'Procedure related adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Musculoskeletal and connective tissue disorders', 'notes': 'Procedure related adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neoplasms benign, malignant and unspecifie', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minimally Invasive Lumbar Decompression (MILD)', 'description': 'Image guided minimally-invasive lumbar decompression\n\nMinimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.'}, {'id': 'OG001', 'title': 'Epidural Steroid Injection (ESI)', 'description': 'An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.\n\nEpidural Steroid Injection: Injection of epidural steroids into the lumbar spine'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minimally Invasive Lumbar Decompression (MILD)', 'description': 'Image guided minimally-invasive lumbar decompression\n\nMinimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.'}, {'id': 'OG001', 'title': 'Epidural Steroid Injection (ESI)', 'description': 'An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.\n\nEpidural Steroid Injection: Injection of epidural steroids into the lumbar spine'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minimally Invasive Lumbar Decompression (MILD)', 'description': 'Image guided minimally-invasive lumbar decompression\n\nMinimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.'}, {'id': 'OG001', 'title': 'Epidural Steroid Injection (ESI)', 'description': 'An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.\n\nEpidural Steroid Injection: Injection of epidural steroids into the lumbar spine'}], 'classes': [{'title': 'Symptom Severity', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Physical Function', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Patient Satisfaction', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Minimally Invasive Lumbar Decompression (MILD)', 'description': 'Image guided minimally-invasive lumbar decompression\n\nMinimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.'}, {'id': 'FG001', 'title': 'Epidural Steroid Injection (ESI)', 'description': 'An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.\n\nEpidural Steroid Injection: Injection of epidural steroids into the lumbar spine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MILD', 'description': 'Image guided minimally-invasive lumbar decompression\n\nMinimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.'}, {'id': 'BG001', 'title': 'Epidural Steroid Injection (ESI)', 'description': 'An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.\n\nEpidural Steroid Injection: Injection of epidural steroids into the lumbar spine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75.6', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '75.0', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '75.3', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], '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': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ODI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.0', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '52.3', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire.\n\n0 to 20: Minimal disability 21-40: Moderate Disability 41-60: Severe Disability 61-80: Crippling back pain 81-100: These patients are either bed-bound or have an exaggeration of their symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NPRS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ZCQ', 'classes': [{'title': 'Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'BG002'}]}]}, {'title': 'Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '2.8', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Zurich Claudication Questionnaire (ZCQ) is a disease-specific self-report outcome. The ZCQ quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. The scale relates to symptoms over the past month.\n\nZCQ consists of three subscales:\n\n1. Symptom severity scale (questions I-VII) Possible range of the score is 1 to 5.\n2. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4.\n3. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2014-03-18', 'resultsFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-15', 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months', 'timeFrame': '12 months', 'description': 'Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months', 'timeFrame': '12 months', 'description': 'Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.'}, {'measure': 'Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months', 'timeFrame': '12 months', 'description': 'Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lumbar Spinal Stenosis', 'Spinal Stenosis', 'Neurogenic Claudication'], 'conditions': ['Spinal Stenosis, Lumbar Region, With Neurogenic Claudication']}, 'referencesModule': {'references': [{'pmid': '30199512', 'type': 'DERIVED', 'citation': 'Staats PS, Chafin TB, Golovac S, Kim CK, Li S, Richardson WB, Vallejo R, Wahezi SE, Washabaugh EP 3rd, Benyamin RM; MiDAS ENCORE Investigators. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018 Oct;43(7):789-794. doi: 10.1097/AAP.0000000000000868.'}, {'pmid': '27228511', 'type': 'DERIVED', 'citation': 'Benyamin RM, Staats PS, MiDAS Encore I. MILD(R) Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016 May;19(4):229-42.'}, {'pmid': '26815247', 'type': 'DERIVED', 'citation': 'Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results. Pain Physician. 2016 Feb;19(2):25-38.'}]}, 'descriptionModule': {'briefSummary': 'Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 65 years or older and a Medicare beneficiary.\n2. Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.\n3. LSS with neurogenic claudication diagnosed via:\n\n 1. Symptomatic diagnosis and\n 2. Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum \\>2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit.\n4. Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.\n5. Available to complete 6 month and one year follow-up visits.\n\nExclusion Criteria:\n\n1. ODI Score \\< 31 (0-100 ODI Scale).\n2. NPRS Score \\< 5 (0-10 NPRS Scale).\n3. Prior surgery at any treatment level.\n4. History of recent spinal fractures with current related pain symptoms.\n5. Patients with Grade III or higher spondylolisthesis.\n6. Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g., acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).\n7. Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance.\n8. Patients previously randomized and/or treated in this clinical study.\n9. Patients that have previously received the MILD procedure.\n10. ESI during eight weeks prior to study enrollment.\n11. Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).\n12. On (or pending) Workman's Compensation or known to be considering litigation associated with back pain."}, 'identificationModule': {'nctId': 'NCT02093520', 'briefTitle': 'The MiDAS ENCORE Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertos Medical, Inc.'}, 'officialTitle': 'MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication', 'orgStudyIdInfo': {'id': 'MiDAS ENCORE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MILD', 'description': 'The MILD procedure is an image-guided minimally-invasive lumbar decompression', 'interventionNames': ['Procedure: MILD Procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural Steroid Injection (ESI)', 'description': 'An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.', 'interventionNames': ['Drug: Epidural Steroid Injection']}], 'interventions': [{'name': 'MILD Procedure', 'type': 'PROCEDURE', 'otherNames': ['MILD lumbar decompression'], 'description': 'The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.', 'armGroupLabels': ['MILD']}, {'name': 'Epidural Steroid Injection', 'type': 'DRUG', 'otherNames': ['ESI'], 'description': 'Injection of epidural steroids into the lumbar spine', 'armGroupLabels': ['Epidural Steroid Injection (ESI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91914', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Synovation Medical Group', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Spine Intervention Medical Group/Fresno Surgical Hospital', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'The Spine Institute', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Newport Beach Headache and Pain', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Millennium Pain Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '40601', 'city': 'Frankfort', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Frankfort Pain Clinic', 'geoPoint': {'lat': 38.20091, 'lon': -84.87328}}, {'zip': '48183', 'city': 'Cherry Island', 'state': 'Michigan', 'country': 'United States', 'facility': 'MI Interventional Pain Center', 'geoPoint': {'lat': 42.0806, 'lon': -83.19465}}, {'zip': '48198', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Pain Specialist', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Pain Management', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07702', 'city': 'Shrewsbury', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Premier Pain', 'geoPoint': {'lat': 40.32955, 'lon': -74.06153}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Southern Spine Institute', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'SC Spine and Pain Specialists', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}], 'overallOfficials': [{'name': 'Ramsin Benyamin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AAPM; ASIPP; ISIS; ASA'}, {'name': 'Peter Staats, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AAPM; ASIPP; ASA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertos Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}