Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-28 @ 12:00 AM
Study NCT ID:
NCT02805504
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dbaldwin@llu.edu', 'phone': '909 558 4196', 'title': 'Duane Baldwin, MD Director of Urologic Research', 'organization': 'Loma Linda University Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': '30-days postoperatively', 'eventGroups': [{'id': 'EG000', 'title': 'Exparel', 'description': 'This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.\n\nExparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Marcaine', 'description': 'This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.\n\nMarcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 0, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Postoperative Ileus', 'notes': 'Postoperative ileus managed conservatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative Bleeding', 'notes': 'Postoperative bleeding requiring blood transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative Hypotension', 'notes': 'Postoperative hypotension or dehydration requiring fluid management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stricture', 'notes': 'Postoperative stricture requiring dilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.\n\nExparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.\n\nNo reportable study outcome data is available per IRB determination after study closure.'}, {'id': 'OG001', 'title': 'Marcaine', 'description': 'This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.\n\nMarcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.\n\nNo reportable study outcome data is available per IRB determination after study closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '16.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative days 1-3', 'description': 'Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively', 'unitOfMeasure': 'morphine equivalent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.'}, {'type': 'PRIMARY', 'title': 'Postoperative Pain Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.\n\nExparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.\n\nNo reportable study outcome data is available per IRB determination after study closure.'}, {'id': 'OG001', 'title': 'Marcaine', 'description': 'This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.\n\nMarcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative day 1', 'description': 'Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.'}, {'type': 'PRIMARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.\n\nExparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.\n\nNo reportable study outcome data is available per IRB determination after study closure.'}, {'id': 'OG001', 'title': 'Marcaine', 'description': 'This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.\n\nMarcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '31.8', 'groupId': 'OG000'}, {'value': '36', 'spread': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of stay in hours', 'description': 'Duration of hospital stay after the surgery until time of discharge', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.'}, {'type': 'PRIMARY', 'title': 'Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.\n\nExparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.\n\nNo reportable study outcome data is available per IRB determination after study closure.'}, {'id': 'OG001', 'title': 'Marcaine', 'description': 'This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.\n\nMarcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days postoperatively', 'description': 'Any complication related to the surgery within 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exparel', 'description': 'This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.\n\nExparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.'}, {'id': 'FG001', 'title': 'Marcaine', 'description': 'This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.\n\nMarcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exparel', 'description': 'This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.\n\nExparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.'}, {'id': 'BG001', 'title': 'Marcaine', 'description': 'This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.\n\nMarcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '30', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '62.7', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '62.2', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-11', 'size': 189556, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-05T18:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2016-06-14', 'resultsFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-29', 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Opioid Consumption', 'timeFrame': 'Postoperative days 1-3', 'description': 'Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively'}, {'measure': 'Postoperative Pain Assessment', 'timeFrame': 'Postoperative day 1', 'description': 'Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Duration of stay in hours', 'description': 'Duration of hospital stay after the surgery until time of discharge'}, {'measure': 'Postoperative Complications', 'timeFrame': '30 days postoperatively', 'description': 'Any complication related to the surgery within 30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bupivacaine', 'Minimally Invasive Surgical Procedures'], 'conditions': ['Urinary Tract Diseases']}, 'referencesModule': {'references': [{'pmid': '26307232', 'type': 'BACKGROUND', 'citation': 'Abdelsattar JM, Boughey JC, Fahy AS, Jakub JW, Farley DR, Hieken TJ, Degnim AC, Goede W, Mohan AT, Harmsen WS, Niesen AD, Tran NV, Bakri K, Jacobson SR, Lemaine V, Saint-Cyr M. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol. 2016 Feb;23(2):465-70. doi: 10.1245/s10434-015-4833-4. Epub 2015 Aug 26.'}, {'pmid': '26056753', 'type': 'BACKGROUND', 'citation': 'Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.'}, {'pmid': '25940854', 'type': 'BACKGROUND', 'citation': 'White S, Vaughan C, Raiff D, Eward W, Bolognesi M. Impact of liposomal bupivacaine administration on postoperative pain in patients undergoing total knee replacement. Pharmacotherapy. 2015 May;35(5):477-81. doi: 10.1002/phar.1587. Epub 2015 May 4.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.', 'detailedDescription': 'A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries. Subjects of prospective study will be randomly divided using electronic program into two groups:\n\nThe first group will receive intraoperative local Liposomal Bupivacaine injection at the port placement site. The control group will receive will local Marcaine (bupivacaine HCl) injection\n\nPrimary Outcome Measures:\n\n* Total opioid consumption measured in intravenous morphine equivalents dose during the postoperative hospital Stay\n* Postoperative pain assessment using visual Analog Pain Scores \\& Brief Pain Inventory form.\n* Length of Hospital Stay\n* Time to First Opioid Use.\n* Postoperative Constipation , paralytic ileus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing urologic surgery.\n\nExclusion Criteria:\n\n* Pregnant and/or nursing mothers.\n* Allergy to bupivacaine.\n* History of drug/alcohol abuse.\n* Severe cardiovascular, hepatic, renal disease or neurological impairment.'}, 'identificationModule': {'nctId': 'NCT02805504', 'briefTitle': 'Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures', 'orgStudyIdInfo': {'id': '5160165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exparel', 'description': 'This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.', 'interventionNames': ['Drug: Exparel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Marcaine', 'description': 'This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.', 'interventionNames': ['Drug: Marcaine']}], 'interventions': [{'name': 'Exparel', 'type': 'DRUG', 'otherNames': ['liposomal bupivacaine'], 'description': 'This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.', 'armGroupLabels': ['Exparel']}, {'name': 'Marcaine', 'type': 'DRUG', 'otherNames': ['Bupivacaine HCl'], 'description': 'This group will receive intraoperative Bupivacaine HCl injection at the surgical site.', 'armGroupLabels': ['Marcaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Mohamed Keheila, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Loma Linda University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'D. Duane Baldwin', 'investigatorAffiliation': 'Loma Linda University'}}}}