Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-29 @ 10:12 PM
Study NCT ID:
NCT05429203
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
Sponsor:
Organization:
Raw JSON
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System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020698', 'term': 'Duodenoscopes'}], 'ancestors': [{'id': 'D020776', 'term': 'Endoscopes, Gastrointestinal'}, {'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'subhas.banerjee@stanford.edu', 'phone': '(650) 736-5555', 'title': 'Subhas Banerjee, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Duodenoscope With Disposable Distal End Caps', 'description': 'Patients will undergo ERCP using a duodenoscope with a single-use distal cover.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 8, 'seriousNumAtRisk': 159, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Conventional Reusable Duodenoscope', 'description': 'Patients will undergo ERCP using a conventional duodenoscope.', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 8, 'seriousNumAtRisk': 160, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Abdomen pain (without post-ERCP pancreatitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Post ERCP pancreatitis (PEP)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-sphincterotomy bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver failure', 'notes': 'Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodenoscope With Disposable Distal End Caps', 'description': 'Patients will undergo ERCP using a duodenoscope with a single-use distal cover.'}, {'id': 'OG001', 'title': 'Conventional Reusable Duodenoscope', 'description': 'Patients will undergo ERCP using a conventional duodenoscope.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duodenoscope Maneuverability: Intubation Into Esophagus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodenoscope With Disposable Distal End Caps', 'description': 'Patients will undergo ERCP using a duodenoscope with a single-use distal cover.'}, {'id': 'OG001', 'title': 'Conventional Reusable Duodenoscope', 'description': 'Patients will undergo ERCP using a conventional duodenoscope.'}], 'classes': [{'title': 'Rating = 1', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duodenoscope Maneuverability: Passage Into Stomach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodenoscope With Disposable Distal End Caps', 'description': 'Patients will undergo ERCP using a duodenoscope with a single-use distal cover.'}, {'id': 'OG001', 'title': 'Conventional Reusable Duodenoscope', 'description': 'Patients will undergo ERCP using a conventional duodenoscope.'}], 'classes': [{'title': 'Rating = 1', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duodenoscope Maneuverability: Navigation Across Pylorus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodenoscope With Disposable Distal End Caps', 'description': 'Patients will undergo ERCP using a duodenoscope with a single-use distal cover.'}, {'id': 'OG001', 'title': 'Conventional Reusable Duodenoscope', 'description': 'Patients will undergo ERCP using a conventional duodenoscope.'}], 'classes': [{'title': 'Rating = 1', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure 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'154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duodenoscope Mechanical Characteristics Profile: Scope Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodenoscope With Disposable Distal End Caps', 'description': 'Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover.'}, {'id': 'OG001', 'title': 'Conventional Reusable Duodenoscope', 'description': 'Patients underwent ERCP using a conventional duodenoscope.'}], 'classes': [{'title': 'Rating = 1', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Mechanical characteristics assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodenoscope With Disposable Distal End Caps', 'description': 'Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover.'}, {'id': 'OG001', 'title': 'Conventional Reusable Duodenoscope', 'description': 'Patients underwent ERCP using a conventional duodenoscope.'}], 'classes': [{'title': 'Rating = 1', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Mechanical characteristics assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no water leakage or no difficulty in applying suction or inflating air, 2 minimal leakage or minimal difficulty with suction or inflation, 3 moderate leakage or difficulty, 4 severe leakage or difficulty and 5 unable to perform the requisite function.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodenoscope With Disposable Distal End Caps', 'description': 'Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover.'}, {'id': 'OG001', 'title': 'Conventional Reusable Duodenoscope', 'description': 'Patients underwent ERCP using a conventional duodenoscope.'}], 'classes': [{'title': 'Rating = 1', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rating = 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Mechanical characteristics assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. 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Repeat: Patient who had prior ERCP.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-22', 'size': 391161, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-14T19:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2022-06-17', 'resultsFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2022-06-17', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-25', 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Procedure-related Adverse Events', 'timeFrame': '3 months', 'description': 'Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.'}], 'secondaryOutcomes': [{'measure': 'Duodenoscope Maneuverability: Intubation Into Esophagus', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.'}, {'measure': 'Duodenoscope Maneuverability: Passage Into Stomach', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.'}, {'measure': 'Duodenoscope Maneuverability: Navigation Across Pylorus', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.'}, {'measure': 'Duodenoscope Maneuverability: Achieving Short Position of the Scope', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.'}, {'measure': 'Duodenoscope Maneuverability: Achieving Optimal Papillary Position', 'timeFrame': 'Maneuverability will be assessed only during the procedure (approximately 10 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.'}, {'measure': 'Duodenoscope Mechanical Characteristics Profile: Scope Stiffness', 'timeFrame': 'Mechanical characteristics assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.'}, {'measure': 'Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality', 'timeFrame': 'Mechanical characteristics assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no water leakage or no difficulty in applying suction or inflating air, 2 minimal leakage or minimal difficulty with suction or inflation, 3 moderate leakage or difficulty, 4 severe leakage or difficulty and 5 unable to perform the requisite function.'}, {'measure': 'Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency', 'timeFrame': 'Mechanical characteristics assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.'}, {'measure': 'Duodenoscope Mechanical Characteristics Profile: Hand Strain', 'timeFrame': 'Mechanical characteristics assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no strain, 2 minimal strain, 3 moderate strain, 4 severe strain and 5 unable to complete the procedure.'}, {'measure': 'Duodenoscope Imaging Characteristics Profile: Image Quality', 'timeFrame': 'Imaging characteristics were assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.'}, {'measure': 'Duodenoscope Imaging Characteristics Profile: Image Stability', 'timeFrame': 'Imaging characteristics were assessed only during the procedure (approximately 15 minutes)', 'description': 'Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.'}, {'measure': 'Number of Participant With Procure Success (Ability to Perform Interventions)', 'timeFrame': '30-60 minutes', 'description': 'Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ERCP', 'Duodenoscope', 'Duodenoscope with single-use distal cover'], 'conditions': ['Biliary Disease', 'Pancreatic Disease', 'Choledocholithiasis', 'Biliary Obstruction', 'Biliary Tract Neoplasms', 'Pancreatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '33007136', 'type': 'BACKGROUND', 'citation': 'Bang JY, Rosch T, Kim HM, Thakkar S, Robalino Gonzaga E, Tharian B, Inamdar S, Lee LS, Yachimski P, Jamidar P, Muniraj T, DiMaio C, Kumta N, Sethi A, Draganov P, Yang D, Seoud T, Perisetti A, Bondi G, Kirtane S, Hawes R, Wilcox CM, Kozarek R, Reddy DN, Varadarajulu S. Prospective evaluation of an assessment tool for technical performance of duodenoscopes. Dig Endosc. 2021 Jul;33(5):822-828. doi: 10.1111/den.13856. Epub 2020 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.', 'detailedDescription': 'The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing ERCP for biliary and pancreatic conditions\n* Age \\> 18 years old\n\nExclusion Criteria:\n\n* Vulnerable patient groups including pregnant women\n* Patients who are unable to consent\n* Patients with known cholangitis\n* Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection\n* Surgically altered anatomy except for Billroth I'}, 'identificationModule': {'nctId': 'NCT05429203', 'briefTitle': 'Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '65189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Duodenoscope with single-use distal cover', 'description': 'Patients will undergo ERCP using a duodenoscope with a single-use distal cover', 'interventionNames': ['Device: Duodenoscope with single-use distal cover']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Duodenoscope', 'description': 'Patients will undergo ERCP using a conventional duodenoscope', 'interventionNames': ['Device: Conventional duodenoscope']}], 'interventions': [{'name': 'Duodenoscope with single-use distal cover', 'type': 'DEVICE', 'description': 'Newer duodenoscope with a single-use distal cover', 'armGroupLabels': ['Duodenoscope with single-use distal cover']}, {'name': 'Conventional duodenoscope', 'type': 'DEVICE', 'description': 'Conventional duodenoscope with standard methods of reprocessing', 'armGroupLabels': ['Conventional Duodenoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '943305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford hospital', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Subhas Banerjee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Subhas Banerjee', 'investigatorAffiliation': 'Stanford University'}}}}