Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:00 AM
Study NCT ID:
NCT06790134
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2025-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of an AI-Assisted Pancreatic EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The completeness for standard station scanning', 'timeFrame': '1 year', 'description': 'The primary outcome measure was the completeness for standard station scanning of EUS by endoscopists in the two groups. This was calculated as the number of stations successfully scanned divided by the total number of stations that should have been scanned.'}], 'secondaryOutcomes': [{'measure': 'The completeness of anatomical structure scanning', 'timeFrame': '1 year', 'description': 'It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned.'}, {'measure': 'Procedure time', 'timeFrame': '1 year', 'description': 'It defined as the observation time only, excluding the time spent on puncture, elastography, contrast-enhanced ultrasound, or other lesion observation or treatment.'}, {'measure': 'The incidence of adverse events', 'timeFrame': '1 year', 'description': 'The incidence of adverse events in both groups during the entire research process.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Diseases']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to verify the auxiliary role of the artificial intelligence (AI) system in pancreatic endoscopic ultrasound (EUS) scans. The main questions it aims to answer are as follows:\n\n1. A comparison of the image recognition accuracy between the AI system and EUS endoscopists.\n2. Whether the AI system can improve the quality of scans for EUS endoscopists. Participants will conduct EUS scanning with or without the assistance of the AI system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Age ≥18 years old, \\<80 years old 2.Patients who need endoscopic ultrasonography of pancreas; 3. Agree to participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria cannot be selected for this trial:\n\nFirst. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography:\n\nPoor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc. Anesthesia assessment failed Pregnancy or breastfeeding In the acute stage of chemical and corrosive injury, it is very easy to cause perforation Recent acute coronary syndrome or clinically unstable ischemic heart attack Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure\\> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.\n\nSecond. Disagree to participate in this study.\n\nThird. There are other problems that do not meet the requirements of this research or that affect the results of the research:\n\nPancreatic disease has undergone surgery or radiotherapy and chemotherapy beforehand; Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up."}, 'identificationModule': {'nctId': 'NCT06790134', 'briefTitle': 'Validation of an AI-Assisted Pancreatic EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'The Third Xiangya Hospital of Central South University'}, 'officialTitle': 'Validation of an AI-Assisted Pancreatic EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial', 'orgStudyIdInfo': {'id': '2023-EUS-AI-001-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI-assisted group', 'description': 'Endoscopists perform scans with the assistance of AI device.', 'interventionNames': ['Device: Artificial intelligence device']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Endoscopists perform scans without the assistance of AI device.'}], 'interventions': [{'name': 'Artificial intelligence device', 'type': 'DEVICE', 'description': 'This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.', 'armGroupLabels': ['AI-assisted group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyan Wang, Doctor', 'role': 'CONTACT', 'email': 'wangxiaoyan@csu.edu.cn', 'phone': '+8613974889301'}], 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Xiaoyan Wang, Doctor', 'role': 'CONTACT', 'email': 'wangxiaoyan@csu.edu.cn', 'phone': '+8613974889301'}], 'overallOfficials': [{'name': 'Xiaoyan Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Third Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Some data underlying this trial cannot be shared publicly due to protection of participant's privacy."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First affiliated hospital of Nanhua University', 'class': 'UNKNOWN'}, {'name': 'the Affiliated Nanhua Hospital, University of South China', 'class': 'UNKNOWN'}, {'name': 'ZhuZhou Central Hospital', 'class': 'OTHER'}, {'name': "First People's Hospital of Chenzhou", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}