Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-02-20 @ 9:22 PM
Study NCT ID:
NCT01242995
Status:
WITHDRAWN
Last Update Posted:
2015-05-07
First Post:
2010-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Retrograde Cholangiopancreatography (ERCP) With Cholangiopancreatoscopy Using a Thin Scope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The device was withdrawn from clinical use', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-06', 'studyFirstSubmitDate': '2010-11-16', 'studyFirstSubmitQcDate': '2010-11-16', 'lastUpdatePostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'use of a thin endoscope system for the evaluation and/or treatment of pancreatobiliary disorders.', 'timeFrame': 'approxiamtely 2-4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Disorders of the Pancreatobiliary System']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the use of a thin scope/anchoring Balloon endoscopy system for the medical care of pancreatic and/or biliary disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have a medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is 18 years or older\n2. Subject has clinical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangioscopy and/or pancreatoscopy\n3. Subject must be able to give informed consent.\n\nExclusion Criteria:\n\n1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)\n2. The subject is unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT01242995', 'briefTitle': 'Endoscopic Retrograde Cholangiopancreatography (ERCP) With Cholangiopancreatoscopy Using a Thin Scope', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Prospective Evaluation of the Clinical Utility of the Thin Scope/Anchoring Balloon Cholangiopancreatoscopy System for Disorders fo the Pancreatobiliary System', 'orgStudyIdInfo': {'id': 'Thin Scope'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pancreatobiliary disorders/thin scope', 'description': 'All patients will be evaluated with cholangioscopy and/or pancreatoscopy using the thin scope.', 'interventionNames': ['Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope']}], 'interventions': [{'name': 'Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope', 'type': 'PROCEDURE', 'description': 'Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy using the thin scope system.', 'armGroupLabels': ['pancreatobiliary disorders/thin scope']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Peter Draganov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}