Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT02524418
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}], 'ancestors': [{'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter.draganov@medicine.ufl.edu', 'phone': '352-273-9472', 'title': 'Dr. Peter V. Draganov MD', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cholangiopancreatoscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.', 'otherNumAtRisk': 75, 'otherNumAffected': 3, 'seriousNumAtRisk': 75, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'mild Post ERCP pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'periampullary perforation', 'notes': 'Serious AE with periampullary perforation caused by biliary sphincterotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Procedure Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangioscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}, {'id': 'OG001', 'title': 'Pancreatoscopy', 'description': 'These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Five of the subjects had both Cholangioscopy and Pancreatoscopy. The results of these procedures were recorded and analyzed separately'}, {'type': 'SECONDARY', 'title': 'Time to Set-up the Spyglass DS for the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangiopancreatoscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2.61', 'upperLimit': '7.39'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 2 hours', 'description': 'The time it takes to set up the Spyglass DS and related equipment for the procedure.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In 20 procedures, the Spyglass equipment set up was done after ERCP started and this time was recorded. The Investigators did not record the set up time for the other procedures.'}, {'type': 'SECONDARY', 'title': 'Measurement of Total Procedure Time Using the Spyglass DS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}, {'units': 'number of Spyglass procedures', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangiopancreatoscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '39.1', 'upperLimit': '89.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 2 hours', 'description': 'Time in minutes will be calculated for completing the procedure with the Spyglass DS.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of Spyglass procedures', 'denomUnitsSelected': 'number of Spyglass procedures', 'populationDescription': '83 Spyglass procedures were conducted on the 75 participants'}, {'type': 'SECONDARY', 'title': 'Measurement in Minutes for Spyglass DS Diagnostic Maneuvers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}, {'units': 'number of Spyglass Proceudres', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangiopancreatoscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '44.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 2 hours', 'description': 'The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of Spyglass Proceudres', 'denomUnitsSelected': 'number of Spyglass Proceudres', 'populationDescription': '83 Spyglass procedures were performed on the 75 participants'}, {'type': 'SECONDARY', 'title': 'Measurement in Minutes for Spyglass DS Therapeutic Maneuvers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Number of Procedures analyzed', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangiopancreatoscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '5.76', 'upperLimit': '18.44'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 2 hours', 'description': 'The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Procedures analyzed', 'denomUnitsSelected': 'Number of Procedures analyzed', 'populationDescription': 'For the 75 participants in the study, 83 procedures were completed. Of the 83 procedures, sampling was attempted on 37 procedures in 27 participants.'}, {'type': 'SECONDARY', 'title': 'Number of Cholangioscopic Exams That Detected Ductal Stones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'total number of exams', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangioscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}, {'id': 'OG001', 'title': 'Pancreatoscopy', 'description': 'Subject who had a Pancreatoscopy as part of their ERCP'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The abnormalities found during the procedure, such as ductal stones.', 'unitOfMeasure': 'exams', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'total number of exams', 'denomUnitsSelected': 'total number of exams', 'populationDescription': 'There were a total of 78 Cholangioscopic examinations in the 70 subjects in this study; 35 exam found stones. Where as in the Pancreatoscopy arm 5 participants were evaluated with only 3 exams being evaluable..'}, {'type': 'SECONDARY', 'title': 'Strictures Found During the Procedure Will be Measured', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}, {'units': 'attempted Cholangioscopic exams', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangioscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The abnormalities found during the procedure, such as strictures.', 'unitOfMeasure': 'strictures found', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'attempted Cholangioscopic exams', 'denomUnitsSelected': 'attempted Cholangioscopic exams', 'populationDescription': 'A total of 78 Cholangioscopic examinations were attempted'}, {'type': 'SECONDARY', 'title': 'Spybite Sampling Attempts Per Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}, {'units': 'Number of procedures analyzed', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangioscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.94', 'groupId': 'OG000', 'lowerLimit': '2.47', 'upperLimit': '5.41'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The mean number of attempts per procedure', 'unitOfMeasure': 'sampling attempts per procedure', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of procedures analyzed', 'denomUnitsSelected': 'Number of procedures analyzed', 'populationDescription': 'Of the 70 Cholangioscopy participants in the study only 44 participants had non-stone lithotripsy-related indications. Spyglass sampling was attempted in 36 procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Successful Removal of the Biliary or Pancreas Stones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholangioscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Spyglass-guided stone therapy was attempted in 26 patients with biliary stones'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cholangiopancreatoscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cholangiopancreatoscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.\n\nCholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '96'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '88 subjects signed consent but in 13 subjects a Spyglass examination was not done because of the lack of indication after performing standard cholangiography or pancreatography'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-10', 'studyFirstSubmitDate': '2015-08-07', 'resultsFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-10', 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Procedure Technical Success', 'timeFrame': 'Day 1', 'description': 'The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.'}], 'secondaryOutcomes': [{'measure': 'Time to Set-up the Spyglass DS for the Procedure', 'timeFrame': 'approximately 2 hours', 'description': 'The time it takes to set up the Spyglass DS and related equipment for the procedure.'}, {'measure': 'Measurement of Total Procedure Time Using the Spyglass DS', 'timeFrame': 'approximately 2 hours', 'description': 'Time in minutes will be calculated for completing the procedure with the Spyglass DS.'}, {'measure': 'Measurement in Minutes for Spyglass DS Diagnostic Maneuvers', 'timeFrame': 'approximately 2 hours', 'description': 'The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.'}, {'measure': 'Measurement in Minutes for Spyglass DS Therapeutic Maneuvers', 'timeFrame': 'approximately 2 hours', 'description': 'The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.'}, {'measure': 'Number of Cholangioscopic Exams That Detected Ductal Stones', 'timeFrame': 'Day 1', 'description': 'The abnormalities found during the procedure, such as ductal stones.'}, {'measure': 'Strictures Found During the Procedure Will be Measured', 'timeFrame': 'Day 1', 'description': 'The abnormalities found during the procedure, such as strictures.'}, {'measure': 'Spybite Sampling Attempts Per Procedure', 'timeFrame': 'Day 1', 'description': 'The mean number of attempts per procedure'}, {'measure': 'Number of Participants With Successful Removal of the Biliary or Pancreas Stones', 'timeFrame': 'Day 1', 'description': 'The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Main Pancreatic Duct'], 'conditions': ['Biliary Tract Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.', 'detailedDescription': 'Cholangioscopy allows for direct visualization of the bile and pancreatic duct. In 2006, the SpyGlass Direct Visualization System for per-oral cholangiopancreatoscopy was introduced and since then has been shown to provide incremental diagnostic and therapeutic benefits. The main limitations of the original SpyGlass platform are fiber optic visualization system, limited tip angulation, square cut Spy scope tip, and complex multi-component setup. A new generation cholangioscopy platform, SpyGlass DS is currently in clinical use. The new system addresses many of the shortcomings of old platform including digital optics, improved tip angulation, tapered tip and simplified set up. It is unclear at this time whether this technical improvement will translate into better outcomes. Therefore, the investigators want to study the clinical utility of SpyGlass DS by prospectively collecting data on the clinical outcomes of patients undergoing cholangioscopy with Spyglass DS as part of their routine medical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care\n\nExclusion Criteria:\n\n* failure to provide informed consent\n* any contraindications to endoscopy'}, 'identificationModule': {'nctId': 'NCT02524418', 'acronym': 'SPYDS', 'briefTitle': 'Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Prospective Evaluation of the Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) Guided Cholangiopancreatoscopy With the SpyGlass DS.', 'orgStudyIdInfo': {'id': '483-2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cholangiopancreatoscopy', 'description': 'A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.', 'interventionNames': ['Procedure: Cholangiopancreatoscopy']}], 'interventions': [{'name': 'Cholangiopancreatoscopy', 'type': 'PROCEDURE', 'otherNames': ['ERCP'], 'description': 'An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.', 'armGroupLabels': ['Cholangiopancreatoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Peter V Draganov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}