Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-27 @ 10:34 AM
Study NCT ID:
NCT04004533
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Development and Evaluation of a Novel Duodenoscope Assessment Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 745}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-28', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the newly developed duodenoscope assessment tool', 'timeFrame': '6 months', 'description': "Assessment of the internal reliability of the duodenoscope assessment tool will be performed, as determined by the Cronbach's coefficient alpha"}], 'secondaryOutcomes': [{'measure': 'Evaluation of the technical performance of duodenoscopes for performing ERCPs.', 'timeFrame': '1 day', 'description': 'The technical performance of the duodenoscope during each ERCP will be based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component will be graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability).'}, {'measure': 'Assessment of procedural indications for ERCPs', 'timeFrame': '1 day', 'description': 'The procedural indications for performing ERCPs will be assessed'}, {'measure': 'Assessment of cannulation success for ERCPs', 'timeFrame': '1 day', 'description': 'The number of attempts for successful cannulation of the desired duct during an ERCP will be assessed'}, {'measure': 'Assessment of adverse event rates during ERCPs', 'timeFrame': '1 month', 'description': 'The rate of adverse events during an ERCP will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['duodenoscope', 'Endoscopic retrograded cholangiopancreatography', 'duodenoscope assessment tool'], 'conditions': ['Dudoenoscope Assessment Tool']}, 'referencesModule': {'references': [{'pmid': '33007136', 'type': 'DERIVED', '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': 'Endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed using duodenoscopes for the treatment of pancreatic and biliary diseases. Although outcomes in endoscopic retrograde cholangiopancreatography (ERCP) procedures are measured mainly in terms of procedural success and complications, currently there are no objective tools to assess the technical performance of the duodenoscopes.\n\nThe Center for Interventional Endoscopy has maintained a multicenter database that prospectively evaluates the technical performance of duodenoscopes for performing ERCPs. Our objective is to analyze the database in order to summarize the technical performance of duodenoscopes during ERCPs and evaluate the reliability of the duodenoscope assessment tool.', 'detailedDescription': 'Outcomes in ERCP are measured mainly in terms of procedural success and complications. Recently, disposable duodenoscopes have been developed to overcome the challenges associated with reusable duodenoscope-related infections. While it is important to measure the technical performance of the newly developed disposable duodenoscope relative to conventional reusable scopes, presently, there are no objective tools to accomplish this task. The aim of this registry is to assess the reliability of a newly designed assessment tool to evaluate the technical performance of the currently available duodenoscopes. The duodenoscope assessment tool will be completed by each endoscopist after performing the ERCP and this data will be summarized and analyzed to assess the technical performance of the duodenoscopes and also to assess validity of the duodenoscope assessment tool. This is a multicenter study, with data collection from multiple centers across the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient undergoing an ERCP with a duodenoscope and meeting the inclusion criteria will have the technical aspects of the duodenoscope function evaluated using the duodenoscope assessment tool', 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Aged 18 years or older\n2. Undergoing ERCP using a duodenoscope\n\nExclusion Criteria\n\n1. Aged less than 18 years old\n2. Not undergoing ERCP using a duodenoscope'}, 'identificationModule': {'nctId': 'NCT04004533', 'briefTitle': 'The Development and Evaluation of a Novel Duodenoscope Assessment Tool', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'The Development and Evaluation of a Novel Duodenoscope Assessment Tool', 'orgStudyIdInfo': {'id': '1434658'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic retrograde cholangiopancreatography (ERCP)', 'description': 'At the time of each ERCP procedure, information on procedure indication, technical performance of the duodenoscope and adverse events will be collected using a newly designed duodenoscope assessment tool. The duodenoscope assessment tool was developed to measure the technical performance of the duodenoscopes based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component is graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability). Duodenoscope assessment tool also captures data on procedural indications, cannulation success rates and adverse events.', 'interventionNames': ['Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)']}], 'interventions': [{'name': 'Endoscopic retrograde cholangiopancreatography (ERCP)', 'type': 'PROCEDURE', 'description': 'At the time of each ERCP procedure, information on procedure indication, technical performance of the duodenoscope and adverse events will be collected using a newly designed duodenoscope assessment tool. The duodenoscope assessment tool was developed to measure the technical performance of the duodenoscopes based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component is graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability). Duodenoscope assessment tool also captures data on procedural indications, cannulation success rates and adverse events.', 'armGroupLabels': ['Endoscopic retrograde cholangiopancreatography (ERCP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Interventional Endoscopy', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Health', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Shyam Varadarajulu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth Orlando'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}