Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT06017102
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-03-20', 'releaseDate': '2025-03-03'}, {'resetDate': '2025-05-21', 'releaseDate': '2025-05-06'}, {'resetDate': '2025-07-14', 'releaseDate': '2025-06-25'}, {'resetDate': '2025-12-03', 'releaseDate': '2025-11-16'}, {'resetDate': '2025-12-15', 'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2025-03-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}, {'id': 'D001656', 'term': 'Biliary Atresia'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aerosol-generating amount', 'timeFrame': '1-2 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['upper endoscopy', 'biliary atresia'], 'conditions': ['Esophageal Varices']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it aims to answer are:\n\n* Subjects who do wired magnetically assisted capsule endoscopy do not need to open the mouths during the process, this study also want to know whether wired magnetically assisted capsule endoscopy can reduce the generation of droplets.\n* Diagnostic accuracy between traditional esophagogastroduodenoscope and wired magnetically assisted capsule endoscopy in biliary atresia patients with esophageal varices.\n\nParticipants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biliary atresia patients \\> 6 years old\n* Vital signs are stable\n* Without acute gastrointestinal bleeding\n\nExclusion Criteria:\n\n* Patients with metal implants, metal stent, artificial joints, bone plates, and bone screw\n* Patients with electronic devices, such as pacemakers, cochlear implants, or other implanted electronic medical devices\n* Throat or esophageal obstruction leading to dysphagia patients\n* Consciousness disturbance patients unable to swallow\n* Patients with acute upper gastrointestinal bleeding\n* Patients with platelet lower than 40K or PT INR \\> 1.5'}, 'identificationModule': {'nctId': 'NCT06017102', 'briefTitle': 'Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Difference in Aerosol-generating Amount Between Wired Magnetic-assisted Capsule Endoscopy System and Esophagogastroduodenoscopy Examination of Varices in Biliary Atresia Patients', 'orgStudyIdInfo': {'id': '202210059DIPA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wired magnetic assisted capsule endoscopy', 'interventionNames': ['Device: wired magnetic assisted capsule endoscopy']}, {'type': 'OTHER', 'label': 'esophagogastroduodenoscopy', 'interventionNames': ['Device: esophagogastroduodenoscopy']}], 'interventions': [{'name': 'wired magnetic assisted capsule endoscopy', 'type': 'DEVICE', 'description': 'once', 'armGroupLabels': ['wired magnetic assisted capsule endoscopy']}, {'name': 'esophagogastroduodenoscopy', 'type': 'DEVICE', 'description': 'once', 'armGroupLabels': ['esophagogastroduodenoscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jia-Feng Wu, PhD', 'role': 'CONTACT', 'email': 'wjf@ntu.edu.tw', 'phone': '+886 23123456', 'phoneExt': '271718'}, {'name': 'Tzu-Chun Kao', 'role': 'CONTACT', 'email': 'michelle871217@gmail.com', 'phone': '+886 23123456', 'phoneExt': '271737'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insight Medical Solutions', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-03', 'type': 'RELEASE'}, {'date': '2025-03-20', 'type': 'RESET'}, {'date': '2025-05-06', 'type': 'RELEASE'}, {'date': '2025-05-21', 'type': 'RESET'}, {'date': '2025-06-25', 'type': 'RELEASE'}, {'date': '2025-07-14', 'type': 'RESET'}, {'date': '2025-11-16', 'type': 'RELEASE'}, {'date': '2025-12-03', 'type': 'RESET'}, {'date': '2025-12-11', 'type': 'RELEASE'}, {'date': '2025-12-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'National Taiwan University Hospital'}}}}