Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-17 @ 8:16 PM
Study NCT ID:
NCT00867204
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2009-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Versus Long Wire ERCP Systems
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_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2009-03-19', 'studyFirstSubmitQcDate': '2009-03-20', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time for device exchange and stent insertion', 'timeFrame': 'during the ERCP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ERCP', 'Study focus was to compare the performance of the ERCP short-wire device versus the Long-wire device.'], 'conditions': ['Endoscopic Retrograde Cholangiopancreatography']}, 'descriptionModule': {'briefSummary': 'This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study hypothesis is to compare the performance of the Fusion ERCP short-wire system to the traditional Long-wire system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the clinical indication for an ERCP.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing ERCP.\n\nExclusion Criteria:\n\n* Age less than 18 years, pregnant women, patients unable to provide informed concent, prior surgery causing a significant change in the anatomy of the papilla (Billroth II or Roux-en-Y)'}, 'identificationModule': {'nctId': 'NCT00867204', 'acronym': 'ERCP systems', 'briefTitle': 'Short Versus Long Wire ERCP Systems', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Prospective Randomized Blinded Comparison of a Short-wire ERCP System to Traditional Long-wire Devices', 'orgStudyIdInfo': {'id': 'ERCP systems'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Short-wire device', 'description': 'The Fusion Short-wire ERCP device was used', 'interventionNames': ['Procedure: ERCP']}, {'label': 'Long-wire device', 'description': 'The traditional Long-wire ERCP device was used', 'interventionNames': ['Procedure: ERCP']}], 'interventions': [{'name': 'ERCP', 'type': 'PROCEDURE', 'description': 'Patients with clinical indication for ERCP were invited to participate in the Study', 'armGroupLabels': ['Long-wire device', 'Short-wire device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida/Shands UF Endoscopy Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Peter V Draganov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}