Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-07 @ 4:34 AM
Study NCT ID:
NCT03303794
Status:
TERMINATED
Last Update Posted:
2020-03-20
First Post:
2017-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka
Sponsor:
Organization:
Raw JSON
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Patients who scored above 20 were considered fit to discharge.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption During the First 48 Hours After TKA Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivicaine', 'description': '0.25% bupivacaine in patients undergoing total knee arthroplasty\n\n0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty'}, {'id': 'OG001', 'title': 'Bupivicaine + Exparel', 'description': '0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty\n\nExparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty\n\n0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '118'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '128'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the first 48 hours after surgery', 'description': 'Monitor how much opioid patient consumes', 'unitOfMeasure': 'milligram', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores During 48 Hrs Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivicaine', 'description': '0.25% bupivacaine in patients undergoing total knee arthroplasty\n\n0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty'}, {'id': 'OG001', 'title': 'Bupivicaine + Exparel', 'description': '0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty\n\nExparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty\n\n0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '7'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours postoperatively', 'description': 'Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupivicaine', 'description': '0.25% bupivacaine in patients undergoing total knee arthroplasty\n\n0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty'}, {'id': 'FG001', 'title': 'Bupivicaine + Exparel', 'description': '0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty\n\nExparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty\n\n0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupivicaine', 'description': '0.25% bupivacaine in patients undergoing total knee arthroplasty\n\n0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty'}, {'id': 'BG001', 'title': 'Bupivicaine + Exparel', 'description': '0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty\n\nExparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty\n\n0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '75'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '58', 'upperLimit': '77'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '63', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', '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': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-10', 'size': 156937, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-21T12:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Interim Analysis showed no significance', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2017-09-26', 'resultsFirstSubmitDate': '2020-01-21', 'studyFirstSubmitQcDate': '2017-10-05', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-09', 'studyFirstPostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AM-PAC Score to Measure Patients Fitness for Discharge', 'timeFrame': 'Post-Operation Day 1', 'description': 'AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption During the First 48 Hours After TKA Surgery', 'timeFrame': 'During the first 48 hours after surgery', 'description': 'Monitor how much opioid patient consumes'}, {'measure': 'Pain Scores During 48 Hrs Postoperatively', 'timeFrame': '48 hours postoperatively', 'description': 'Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee arthroplasty', 'bupivacaine', 'anesthesia'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '23440367', 'type': 'BACKGROUND', 'citation': 'Johnson RL, Kopp SL, Hebl JR, Erwin PJ, Mantilla CB. Falls and major orthopaedic surgery with peripheral nerve blockade: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):518-28. doi: 10.1093/bja/aet013. Epub 2013 Feb 24.'}, {'pmid': '19258965', 'type': 'BACKGROUND', 'citation': 'Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7.'}, {'pmid': '16326725', 'type': 'BACKGROUND', 'citation': 'Hebl JR, Kopp SL, Ali MH, Horlocker TT, Dilger JA, Lennon RL, Williams BA, Hanssen AD, Pagnano MW. A comprehensive anesthesia protocol that emphasizes peripheral nerve blockade for total knee and total hip arthroplasty. J Bone Joint Surg Am. 2005;87 Suppl 2:63-70. doi: 10.2106/JBJS.E.00491. No abstract available.'}, {'pmid': '18362603', 'type': 'BACKGROUND', 'citation': 'Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.'}, {'pmid': '19553071', 'type': 'BACKGROUND', 'citation': 'Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.'}, {'pmid': '18719448', 'type': 'BACKGROUND', 'citation': 'Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.'}, {'pmid': '20889937', 'type': 'BACKGROUND', 'citation': 'Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.'}, {'pmid': '19046884', 'type': 'BACKGROUND', 'citation': 'Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.'}, {'pmid': '11772802', 'type': 'BACKGROUND', 'citation': 'Klein SM, Nielsen KC, Greengrass RA, Warner DS, Martin A, Steele SM. Ambulatory discharge after long-acting peripheral nerve blockade: 2382 blocks with ropivacaine. Anesth Analg. 2002 Jan;94(1):65-70, table of contents. doi: 10.1097/00000539-200201000-00012.'}, {'pmid': '17196495', 'type': 'BACKGROUND', 'citation': 'Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.'}, {'pmid': '19680735', 'type': 'BACKGROUND', 'citation': 'Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.'}, {'pmid': '17377133', 'type': 'BACKGROUND', 'citation': 'Williams BA, Kentor ML, Bottegal MT. The incidence of falls at home in patients with perineural femoral catheters: a retrospective summary of a randomized clinical trial. 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Activity outcome measurement for postacute care. Med Care. 2004 Jan;42(1 Suppl):I49-61. doi: 10.1097/01.mlr.0000103520.43902.6c.'}, {'pmid': '24764073', 'type': 'BACKGROUND', 'citation': 'Jette DU, Stilphen M, Ranganathan VK, Passek SD, Frost FS, Jette AM. AM-PAC "6-Clicks" functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014 Sep;94(9):1252-61. doi: 10.2522/ptj.20130359. Epub 2014 Apr 24.'}, {'pmid': '26993155', 'type': 'BACKGROUND', 'citation': 'Menendez ME, Schumacher CS, Ring D, Freiberg AA, Rubash HE, Kwon YM. Does "6-Clicks" Day 1 Postoperative Mobility Score Predict Discharge Disposition After Total Hip and Knee Arthroplasties? J Arthroplasty. 2016 Sep;31(9):1916-20. doi: 10.1016/j.arth.2016.02.017. Epub 2016 Feb 17.'}, {'pmid': '17000826', 'type': 'BACKGROUND', 'citation': 'Bickler P, Brandes J, Lee M, Bozic K, Chesbro B, Claassen J. 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Reg Anesth Pain Med. 2014 Sep-Oct;39(5):414-7. doi: 10.1097/AAP.0000000000000127.'}, {'pmid': '17377115', 'type': 'BACKGROUND', 'citation': 'Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. doi: 10.1213/01.ane.0000258740.17193.ec.'}]}, 'descriptionModule': {'briefSummary': "Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.", 'detailedDescription': 'This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of this study is the proportion of patients "fit to discharge" on postoperative day one. Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel) uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been used in clinical practice for decades for peripheral nerve block, spinal, and epidural analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine for up to 72 hours with a single injection. The study was designed to compare two of our current standard therapies:\n\n1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and\n2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing unilateral total knee replacement due to OA or rheumatoid arthritis\n* Ages 40- 80 years old\n* American Society of Anesthesiologists class I-III\n\nExclusion Criteria:\n\n* Refusal or absolute medical contraindication to peripheral nerve block\n* refusal or absolute medical contraindication to spinal anesthesia\n* conversion of spinal anesthesia to general anesthesia is obtained\n* inability to cooperate\n* allergy to any drug used in this study\n* daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)\n* alcohol dependence or use of any illegal drugs within the last month\n* inability to perform the mobilization test and timed up and go (TUG) test pre-operatively'}, 'identificationModule': {'nctId': 'NCT03303794', 'briefTitle': '0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Comparative Feasibility and Efficacy of a Five Compartment Technique Using 0.25% Bupivacaine vs a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka; a Single Blinded Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2017-7893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivicaine', 'description': '0.25% bupivacaine in patients undergoing total knee arthroplasty', 'interventionNames': ['Drug: 0.25% bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivicaine + Exparel', 'description': '0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty', 'interventionNames': ['Drug: Exparel', 'Drug: 0.25% bupivacaine']}], 'interventions': [{'name': 'Exparel', 'type': 'DRUG', 'description': '1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty', 'armGroupLabels': ['Bupivicaine + Exparel']}, {'name': '0.25% bupivacaine', 'type': 'DRUG', 'otherNames': ['liposomal'], 'description': '0.25% bupivacaine in patients undergoing total knee arthroplasty', 'armGroupLabels': ['Bupivicaine', 'Bupivicaine + Exparel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Hutchinson Campus', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Boleslav Kosharskyy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All study data will be collected and entered into the computer database. Each subject will be assigned to a random number code and the key linking the code and the subject identifier will be stored in a locked cabinet. The computer database will be password protected and will be kept on the Montefiore drive. The research manager is responsible for auditing the consistency of the data transcribed from the paper case report form to the computer. A protocol violation log will be maintained and all protocol violations will be reported to the Institutional Review Board and Data Safety Monitoring Board. The planned interim analysis (half way through the recruitment) will be mainly focused on the adverse events, rather than the efficacy of the procedure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Singh Nair', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}