Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-27 @ 9:13 PM
Study NCT ID:
NCT06974695
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Predictive Factors for Failure of Cholangioscopy-assisted Lithotripsy in the Management of Complex Bile Duct Stones: a Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive factors for failure of cholangioscopy lithotripsy in the management of complex bile duct stone', 'timeFrame': 'Baseline', 'description': 'Cholangioscopy-guided lithotripsy failure: defined as stone clearance requiring more than one lithotripsy session or surgical intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cholangioscopy', 'Spyglass', 'Failure', 'Complex bile duct stone', 'predictive factor', 'electrohydraulic lithotripsy', 'EHL', 'lithotripsy', 'ERCP'], 'conditions': ['Bile Duct Stones']}, 'descriptionModule': {'briefSummary': 'This study aims to optimize the management of complex biliary stones by identifying predictive factors for SpyGlass lithotripsy failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any adult patient who underwent cholangioscopy-guided lithotripsy for bile duct stones between January 1, 2018, and May 30, 2025', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult patient who underwent cholangioscopy-guided lithotripsy for bile duct stones between January 1, 2018, and May 30, 2025\n\nExclusion Criteria:\n\n* Patient who objected to the collection of their data'}, 'identificationModule': {'nctId': 'NCT06974695', 'acronym': 'CLEVER', 'briefTitle': 'Identification of Predictive Factors for Failure of Cholangioscopy-assisted Lithotripsy in the Management of Complex Bile Duct Stones: a Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Predictive Factors for Cholangioscopy-Assisted Lithotripsy Failure in the Management of Complex Biliary Stones: A Retrospective Analysis', 'orgStudyIdInfo': {'id': '2025_PI_011'}}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Lorraine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion SCHAEFER, Hospital practionner', 'role': 'CONTACT', 'email': 'm.schaefer@chru-nancy.fr'}, {'name': 'Raphaël Bouchès, Resident', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHRU Brabois Vandoeuvre les Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Marion SCHAEFER, hospital practitioner', 'role': 'CONTACT', 'email': 'm.schaefer@chru-nancy.fr'}], 'overallOfficials': [{'name': 'Marion SCHAEFER, hospital practitioner', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital practitioner', 'investigatorFullName': 'Marion SCHAEFER', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}