Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-28 @ 4:57 AM
Study NCT ID:
NCT05481632
Status:
COMPLETED
Last Update Posted:
2022-08-01
First Post:
2022-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007417', 'term': 'Intestinal Polyps'}], 'ancestors': [{'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity of polyps identification', 'timeFrame': '3 months', 'description': 'The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.'}, {'measure': 'specificity of polyps identification', 'timeFrame': '3 months', 'description': 'The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.'}], 'secondaryOutcomes': [{'measure': 'Polyp detection rate', 'timeFrame': '3 months', 'description': 'The numerator is subjects with polyps detected and the denominator is all subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intestinal Polyps']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical Technology Co., Ltd.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old ≤ age ≤ 75 years old, male or female;\n* Subjects with colonoscopy diagnosis and screening needs;\n* Sign the Written Informed Consent Form;\n* With full capacity for civil conduct.\n\nExclusion Criteria:\n\n* History of acute myocardial infarction (within 6 months), severe heart, liver, and renal insufficiency or mental disease;\n* Patients who are taking aspirin, warfarin, and other anticoagulants;\n* Patients with inflammatory bowel disease, or polyposis syndromes, or confirmed or highly suspected colon cancer;\n* History of colorectal surgery;\n* Patients with familial adenomatous polyposis;\n* Pregnant women (if the subject is a woman of reproductive age and cannot confirm whether she is pregnant, a pregnancy test is required);\n* Patients who are participating in clinical trials of other drugs or medical devices;\n* Patients who are not eligible to participate in this clinical trial in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT05481632', 'briefTitle': 'Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software', 'orgStudyIdInfo': {'id': 'EndoAngel -CTP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physician AI-assisted diagnosis group', 'interventionNames': ['Other: Endoangel assisted the process of colonoscopy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Physician Independent Diagnostic Group', 'interventionNames': ['Other: Colonoscopy was performed without endoangel assistance']}], 'interventions': [{'name': 'Endoangel assisted the process of colonoscopy', 'type': 'OTHER', 'description': 'Endoangel assisted doctors to detect polyps', 'armGroupLabels': ['Physician AI-assisted diagnosis group']}, {'name': 'Colonoscopy was performed without endoangel assistance', 'type': 'OTHER', 'description': 'Polyps were detected without ENDOANGEL assistance', 'armGroupLabels': ['Physician Independent Diagnostic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Wuhan Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}