Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT04456218
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2020-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2020-06-14', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A complete common bile duct accessing rate', 'timeFrame': '1 day', 'description': "To test the device's feasibility"}, {'measure': 'Image quality evaluation: the light brightness and the imaging sharpness in Likert scale', 'timeFrame': '1 day', 'description': "To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better)."}], 'secondaryOutcomes': [{'measure': 'Number of complications (ablation, bleeding, perforation in percentage) or system malfunction', 'timeFrame': '1 day', 'description': "To test the device's safety"}, {'measure': 'In biliary stone arm: The biggest residual stone size (in cm).', 'timeFrame': '1 day', 'description': 'The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)'}, {'measure': 'In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture', 'timeFrame': '1 day', 'description': 'The ability for differential diagnosis of benign or malignant stricture. The specific features include increased vascularity, irregular mucosa/nodularity, luminal narrowing, tumor vessel, mucosal lesion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Tract', 'Neoplasms', 'Stone - Biliary']}, 'descriptionModule': {'briefSummary': 'A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with complicated bile duct stone (stone size \\> 1.5 cm or number of stone \\> 3 )\n* Patients with indeterminate biliary stricture or obstruction\n\nExclusion Criteria:\n\n* Pregnant woman;\n* Patients who are not suitable for ERCP (e.g. behavior disorder, major cognitive-perceptual deficit, etc.).'}, 'identificationModule': {'nctId': 'NCT04456218', 'briefTitle': 'Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract', 'orgStudyIdInfo': {'id': 'A-BR-108-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biliary stone', 'description': 'Participants who meet the criteria of biliary stone enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.', 'interventionNames': ['Device: NCKU-scope-01 (a custom-made biliary endoscope system)']}, {'type': 'EXPERIMENTAL', 'label': 'Biliary stricture', 'description': 'Participants who meet the criteria of biliary neoplasm enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.', 'interventionNames': ['Device: NCKU-scope-01 (a custom-made biliary endoscope system)']}], 'interventions': [{'name': 'NCKU-scope-01 (a custom-made biliary endoscope system)', 'type': 'DEVICE', 'description': 'The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis', 'armGroupLabels': ['Biliary stone', 'Biliary stricture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chiao-Hsiung Chuang', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}