Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT03766035
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2018-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma', 'timeFrame': '12 months', 'description': 'Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation.'}, {'measure': 'POCS-guided Biopsy for Early Detection of Cholangiocarcinoma', 'timeFrame': '12 months', 'description': 'Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure.'}], 'secondaryOutcomes': [{'measure': 'Technical Success - Ability to advance the scope.', 'timeFrame': 'Baseline', 'description': 'Ability to advance the cholangioscope to the target stricture, ability to visualize the stricture and ability to obtain a tissue sample with Spy Bite where applicable.'}, {'measure': 'Rate of Adverse Events', 'timeFrame': 'From index through study completion, an average of one year', 'description': 'Serious adverse events from initial POCS procedure until end of follow-up.'}, {'measure': 'Proportion of patients identified for repeat procedure.', 'timeFrame': 'During index procedure', 'description': 'Proportion of patients identified for repeat procedure considering the addition of Spy Glass DS visualization and Spy Bite biopsy at Index compared to the proportion identified for repeat procedure without consideration of Spy Glass DS visualization and Spy Bite biopsy at Index.'}, {'measure': 'Correspondence of Biopsies', 'timeFrame': 'From index through study completion, an average of one year', 'description': 'Correlation between histopathology of Spy Bite biopsies collected during the initial POCS procedure and final diagnosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['per oral cholangioscopy', 'PSC', 'cholangiocarcinoma', 'primary sclerosing cholangitis', 'ERCP'], 'conditions': ['Primary Sclerosing Cholangitis (PSC)']}, 'descriptionModule': {'briefSummary': 'To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).', 'detailedDescription': 'The primary objective of this study is to demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with PSC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed diagnosis of PSC\n2. Clinical indication for ERCP per local standard of practice, such as suspicion of potential malignancy based on worsening cholestatic values or clinical presentation (such as itching, cholangitis) or new biliary stricture on trans-abdominal imaging (MRI/MRCP, US or CT) or suspicious cytology\n3. Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system based on imaging performed prior to scheduled ERCP\n4. Written informed consent from patient to participate in the study, including compliance with study procedures.\n\nExclusion Criteria:\n\n1. Contraindication for an ERCP or POCS\n2. History of liver transplantation\n3. Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging\n4. History of iatrogenic bile duct trauma, including biliary surgery within 6 months of enrollment\n5. INR \\> 1.5 or platelets count \\< 50,000\n6. Age \\< 18 years\n7. Pregnant women or women trying to become pregnant'}, 'identificationModule': {'nctId': 'NCT03766035', 'briefTitle': 'Cholangioscopy in Primary Sclerosing Cholangitis (PSC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Cholangioscopy in Primary Sclerosing Cholangitis (PSC)', 'orgStudyIdInfo': {'id': 'E7136'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Consented, enrolled PSC patients undergoing ERCP + SpyGlass', 'description': 'Patients with PSC who have been consented and enrolled in the study will undergo ERCP with the addition of SpyGlass as indicated by their treating physician.', 'interventionNames': ['Device: SpyGlass DS I - II']}], 'interventions': [{'name': 'SpyGlass DS I - II', 'type': 'DEVICE', 'description': 'The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.', 'armGroupLabels': ['Consented, enrolled PSC patients undergoing ERCP + SpyGlass']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Davis Hospital', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Health', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital and Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'T3H 0V5', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Aspen Woods Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': '1105 AZ', 'city': 'Amsterdam-Zuidoost', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.3075, 'lon': 4.97222}}, {'zip': '0372', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Rikshospitalet University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Johannes Eksteen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aspen Woods Clinic'}, {'name': 'Douglas Adler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Hospital and Clinic'}, {'name': 'Lars Aabakken, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rikshospitalet Oslo University Hospital'}, {'name': 'Cyriel Ponsioen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'Sooraj Tejaswi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sutter Davis Hospital'}, {'name': 'Christopher Bowlus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}