Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT03653416
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
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H', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Ipack Group', 'description': '20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.\n\nIpack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pai (Peri Articular) Group', 'description': 'Patients received adductor canal catheter and peri articular infiltration.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Narcotic Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipack Group', 'description': '20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. 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Patients received adductor canal catheter and peri articular infiltration as well.\n\nIpack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.'}, {'id': 'OG001', 'title': 'Pai (Peri Articular) Group', 'description': 'Patients received adductor canal catheter and peri articular infiltration.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '7.00'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 24 hours', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PACU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipack Group', 'description': '20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.\n\nIpack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.'}, {'id': 'OG001', 'title': 'Pai (Peri Articular) Group', 'description': 'Patients received adductor canal catheter and peri articular infiltration.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.50', 'upperLimit': '4.51'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'average 24 hours', 'description': 'Post-Anesthesia Care Unit (PACU) length of stay (LOS)', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pain by Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipack Group', 'description': '20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.\n\nIpack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.'}, {'id': 'OG001', 'title': 'Pai (Peri Articular) Group', 'description': 'Patients received adductor canal catheter and peri articular infiltration.'}], 'classes': [{'title': 'Anterior', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Knee', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Lateral', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Medial', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Posterior', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'No Pain', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Location of knee pain as anterior/posterior, medial/lateral', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ambulation Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipack Group', 'description': '20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.\n\nIpack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.'}, {'id': 'OG001', 'title': 'Pai (Peri Articular) Group', 'description': 'Patients received adductor canal catheter and peri articular infiltration.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '74'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-op Day 1', 'description': 'Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bartels Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipack Group', 'description': '20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.\n\nIpack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.'}, {'id': 'OG001', 'title': 'Pai (Peri Articular) Group', 'description': 'Patients received adductor canal catheter and peri articular infiltration.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '53'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '53'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-op Day 1', 'description': "Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. 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Patients received adductor canal catheter and peri articular infiltration as well.\n\nIpack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.'}, {'id': 'FG001', 'title': 'Pai (Peri Articular) Group', 'description': 'Patients received adductor canal catheter and peri articular infiltration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants enrolled from March 2018, and study conducted from June 2018 to August 2019'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pai (Peri Articular) Group', 'description': 'Patients received adductor canal catheter and peri articular infiltration.'}, {'id': 'BG001', 'title': 'Ipack Group', 'description': '20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.\n\nIpack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.65', 'spread': '6.20', 'groupId': 'BG000'}, {'value': '64.67', 'spread': '7.72', 'groupId': 'BG001'}, {'value': '63.66', 'spread': '7.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '32.69', 'spread': '7.27', 'groupId': 'BG000'}, {'value': '31.74', 'spread': '6.34', 'groupId': 'BG001'}, {'value': '32.21', 'spread': '6.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Side of surgery', 'classes': [{'title': 'Left', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Right', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoker', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Use', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'title': 'High School', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': "Bachelor's degree", 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Graduate degree', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Employed Participants', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-22', 'size': 446434, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-13T17:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-11', 'studyFirstSubmitDate': '2018-08-28', 'resultsFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2018-08-29', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-11', 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Narcotic Consumption', 'timeFrame': '24 hours', 'description': 'Narcotic consumption in the first 24 hours'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Score (VAS) for Pain', 'timeFrame': 'at 6, 12, 18, and 24 hours post procedure', 'description': 'Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain.'}, {'measure': 'Time to First Dose of Narcotic Administration', 'timeFrame': 'up to 24 hours'}, {'measure': 'PACU Length of Stay', 'timeFrame': 'average 24 hours', 'description': 'Post-Anesthesia Care Unit (PACU) length of stay (LOS)'}, {'measure': 'Number of Participants With Pain by Location', 'timeFrame': '24 hours', 'description': 'Location of knee pain as anterior/posterior, medial/lateral'}, {'measure': 'Ambulation Distance', 'timeFrame': 'Post-op Day 1', 'description': 'Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT'}, {'measure': 'Bartels Index', 'timeFrame': 'Post-op Day 1', 'description': "Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Total knee arthroplasty', 'Peri articular infiltration', 'Pack block', 'Adductor canal catheter'], 'conditions': ['Osteo Arthritis Knee']}, 'referencesModule': {'references': [{'pmid': '29721648', 'type': 'BACKGROUND', 'citation': 'Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.'}, {'pmid': '35944566', 'type': 'DERIVED', 'citation': 'Bh PP, Jinadu S, Okunlola O, Darkzali H, Lin HM, Lai YH. Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial. J Knee Surg. 2023 Oct;36(12):1289-1296. doi: 10.1055/s-0042-1755355. Epub 2022 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.', 'detailedDescription': 'There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.\n\nThere have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA (American Society of Anesthesiology) class I-IV\n* age 18-75.\n\nExclusion Criteria:\n\n* ASA class V\n* morbid obesity\n* patient refusal\n* patients with chronic pain or on pain medication\n* allergy to LA\n* patients receiving any additional regional techniques\n* coagulopathy\n* patients receiving systemic anticoagulation\n* local infection and procedures anticipated to last more than 5 hours.'}, 'identificationModule': {'nctId': 'NCT03653416', 'briefTitle': "Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty", 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'GCO 17-04304'}, 'secondaryIdInfos': [{'id': 'IRB 17-01981', 'type': 'OTHER', 'domain': 'PPHS, ISMMS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ipack group', 'description': '20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.', 'interventionNames': ['Device: Ipack', 'Drug: Bupivacaine', 'Procedure: Peri Articular Infiltration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pai (peri articular) group', 'description': 'Patients will receive adductor canal catheter and peri articular infiltration.', 'interventionNames': ['Procedure: Peri Articular Infiltration']}], 'interventions': [{'name': 'Ipack', 'type': 'DEVICE', 'description': 'IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.', 'armGroupLabels': ['Ipack group']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': '20 cc of bupivacaine(o.25%) injection', 'armGroupLabels': ['Ipack group']}, {'name': 'Peri Articular Infiltration', 'type': 'PROCEDURE', 'otherNames': ['PAI'], 'description': 'Adductor Canal Catheter and Peri Articular Infiltration', 'armGroupLabels': ['Ipack group', 'Pai (peri articular) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Yan H Lai, MD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ichan School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yan Lai', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}