Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-04-21 @ 10:06 PM
Study NCT ID:
NCT02370056
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of 3D Visualization for Total Colectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GORGUNE@ccf.org', 'phone': '216 444-1244', 'title': 'Dr. Emre Gorgun', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The standard post-operative period of 30 days.', 'eventGroups': [{'id': 'EG000', 'title': '3D Visualization', 'description': '3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.\n\n3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': '2D Visualization', 'description': '2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.\n\n2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'Post-operative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Portal vein thrombosis/Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Operating Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3D Visualization', 'description': '3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.\n\n3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode'}, {'id': 'OG001', 'title': '2D Visualization', 'description': '2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.\n\n2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '30.8', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '38.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 minutes', 'description': 'total operating time', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Major Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3D Visualization', 'description': '3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.\n\n3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode'}, {'id': 'OG001', 'title': '2D Visualization', 'description': '2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.\n\n2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 minutes', 'description': 'Number of Participants with Intraoperative Complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3D Visualization', 'description': '3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.\n\n3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode'}, {'id': 'FG001', 'title': '2D Visualization', 'description': '2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.\n\n2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '3D Visualization', 'description': '3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.\n\n3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode'}, {'id': 'BG001', 'title': '2D Visualization', 'description': '2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.\n\n2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', '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': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.8', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '17.0', 'groupId': 'BG001'}, {'value': '40.0', 'spread': '16.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '53 subjects total were included in analysis'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', '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': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '4.25', 'groupId': 'BG000'}, {'value': '23.9', 'spread': '5.17', 'groupId': 'BG001'}, {'value': '23.5', 'spread': '4.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-06', 'size': 440655, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-08T17:23', 'hasProtocol': True}, {'date': '2018-08-09', 'size': 285817, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-08T17:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2015-02-09', 'resultsFirstSubmitDate': '2020-11-22', 'studyFirstSubmitQcDate': '2015-02-18', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-22', 'studyFirstPostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operating Time', 'timeFrame': '180 minutes', 'description': 'total operating time'}], 'secondaryOutcomes': [{'measure': 'Major Complication', 'timeFrame': '180 minutes', 'description': 'Number of Participants with Intraoperative Complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis', 'detailedDescription': 'Three-dimensional (3D) visualization technology for laparoscopy has been proposed, since the early 1990\'s, as a method to facilitate laparoscopic performance. However, early 3D laparoscopic technology was limited in terms of image quality, so that its use had not been implemented. The latest technical developments ensure high-definition 3D visualization with the same quality that current two-dimensional (2D) systems provide.\n\nThe anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety . It was reported that, 3D laparoscopic visualization offers significant advantages in enhancing laparoscopic performance, even in novice surgeons, comparing to the 2D systems . We hypothesize that 3D visualization may allow surgeons to reduce the overall operating time with a rate of 10% with comparable perioperative and postoperative outcomes. The primary endpoint of this study is to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis. Secondary endpoints are to determine whether 3D visualization confers benefits such as reduced operating time and intra-operative complications with comparable postoperative outcomes.\n\nDevice Description: The EXERA III Universal Platform will be used in this study, in conjunction with the ENDOEYE FLEX 3D. The ENDOEYE FLEX 3D can also be used in 2D mode, by utilizing a programmed button on the handle of the scope, or by using the 2D/3D button on the 3D Visualization Unit. The articulating tip of the ENDOEYE FLEX allows for the scope to be used in both single-site and multi-port procedures, providing critical views and allowing a bird\'s eye view so that the scope is out of the way of other instruments (while still capturing the image at the surgical site). All equipment used in this trial has been cleared under 510(k) approval by the FDA, and has been on the market in the US since April 2013.\n\nThe Olympus HD 3D Laparoscopic Surgical Video System consists of the following components:\n\n* CV-190 Processor\n* CLV-190 Light Source\n* 3DV-190 3D Visualization Unit\n* LMD-2451MT/3G4 Sony 24" 3D Monitor\n* IMH-20 Image Capture System\n* UHI-4 Insufflator\n* K10021611 Cart\n* OL-0015-08 Tall Rollstand\n* LTF-190-10-3D ENDOEYE FLEX 3D Videoscope\n* 3D glasses (regular and clip-on styles)\n\nStudy Size:Mean operating time for laparoscopic subtotal colectomy for medically refractory UC was reported longer with a comparison to open surgery in the recently published studies.\n\nTherefore the effort to decrease operating time in laparoscopic colectomy has gained importance. We assumed that, in order to be able to determine a 10% reduction in mean operating time, each group should include 27 patients (80% power and 5% significance).\n\nPatients who will undergo laparoscopic total abdominal colectomy (TAC) for UC will be included in the study. All subjects will be randomized into two groups: 3D laparoscopy, and 2D laparoscopy. Three staff surgeons (EG, HK, FR) at the department of colorectal surgery, Cleveland Clinic, Ohio will perform the procedures with 2D and 3D laparoscopy. Each surgeon will perform 9 total colectomies with 3D, and 9 total colectomies with the 2D laparoscopy system. In total, 54 patients will be included (27 patients for each group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for surgery must be Ulcerative Colitis\n* Patient age between 18 and 80\n* Elective procedure\n* BMI between 17 and 30\n* Total colectomy with end ileostomy, without proctectomy\n\nExclusion Criteria:\n\n* Any preoperative diagnosis other than UC\n* Patient age\\< 18, or \\>80\n* Emergency surgery\n* Previous gastrointestinal surgery\n* BMI\\>30\n* Pregnancy\n* Presence of any gastrointestinal tract malignancy\n* Segmental colon resections, completion proctectomy, total proctocolectomy, pouch procedures'}, 'identificationModule': {'nctId': 'NCT02370056', 'acronym': '3Dvs2DforUC', 'briefTitle': 'Evaluation of 3D Visualization for Total Colectomy', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Comparative Assessment of Three-dimensional vs. Conventional Laparoscopy in a Total Colectomy Model for Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'CCFJJN4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D Visualization', 'description': '3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated.', 'interventionNames': ['Diagnostic Test: 3-dimensional visualization']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2D Visualization', 'description': '2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.\n\nThis group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated.', 'interventionNames': ['Diagnostic Test: 2-dimensional visualization']}], 'interventions': [{'name': '3-dimensional visualization', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode', 'armGroupLabels': ['3D Visualization']}, {'name': '2-dimensional visualization', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode', 'armGroupLabels': ['2D Visualization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Emre Gorgun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Emre Gorgun', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}