Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT05730192
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Histology of the polyps is performed by the pathologist blinded to the study group assignment.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel trial design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 985}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adenoma per colonoscopy (APC)', 'timeFrame': 'During the procedure/surgery', 'description': 'Superiority of CADDIE Arm vs. control.'}, {'measure': 'Positive percent agreement (PPA)', 'timeFrame': 'During the procedure/surgery', 'description': 'Non inferiority of CADDIE Arm vs. control.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screening', 'Surveillance', 'Artificial Intelligence', 'Colonoscopy'], 'conditions': ['Colorectal Cancer', 'Polyp of Colon', 'Adenoma Colon']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.meditrial.net/', 'label': 'Meditrial Clinical Research Organization'}, {'url': 'https://odin-vision.com/', 'label': 'Odin Vision Cloud Connected Endoscopy'}]}, 'descriptionModule': {'briefSummary': 'The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.', 'detailedDescription': 'The EAGLE study will be conducted with a parallel design. Patients who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADDIE Arm) using CADDIE or standard colonoscopy without CADe (Control Arm). All resected polyps will be submitted for histologic examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Screening or surveillance colonoscopy\n2. Age 40 years or older\n3. Informed consent\n\nExclusion Criteria:\n\n1. Emergency colonoscopies\n2. Inflammatory bowel disease (IBD)\n3. Colorectal Cancer (CRC)\n4. Previous Colorectal Cancer (CRC)\n5. Previous colonic resection\n6. Returning for a planned elective therapeutic colonoscopy.\n7. Polyposis syndromes (familial adenomatous polyposis)\n8. Contraindication for biopsy or polypectomy.'}, 'identificationModule': {'nctId': 'NCT05730192', 'acronym': 'EAGLE', 'briefTitle': 'EAGLE Trial CADDIE Artificial Intelligence Endoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Odin Medical'}, 'officialTitle': 'Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)', 'orgStudyIdInfo': {'id': 'RCT-2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CADDIE colonoscopy (CADDIE Arm)', 'description': 'CADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract.', 'interventionNames': ['Device: CADDIE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard high-definition white light colonoscopy (Control Arm)', 'description': 'Patients will receive a standard colonoscopy', 'interventionNames': ['Device: CADDIE']}], 'interventions': [{'name': 'CADDIE', 'type': 'DEVICE', 'otherNames': ['Colonoscopy'], 'description': 'A colonoscopy is an examination of the bowels using a colonoscope, or a thin, flexible tube with a light and camera. It can help identify issues like colorectal cancer, polyps, and ulcers.', 'armGroupLabels': ['CADDIE colonoscopy (CADDIE Arm)', 'Standard high-definition white light colonoscopy (Control Arm)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Israeli-Georgian Medical Research Clinic Healthycore', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sana Klinikum Lichtenberg', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '21100', 'city': 'Castellanza', 'state': 'Varese', 'country': 'Italy', 'facility': 'Humanitas Mater Domini', 'geoPoint': {'lat': 45.61079, 'lon': 8.89616}}, {'zip': '95045', 'city': 'Catania', 'country': 'Italy', 'facility': 'Humanitas Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '20089', 'city': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '43-100', 'city': 'Tychy', 'country': 'Poland', 'facility': 'H-T. Centrum Medyczne', 'geoPoint': {'lat': 50.13717, 'lon': 18.96641}}, {'zip': '00-001', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'The Maria Sklodowska-Curie National Research Institute of Oncology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '00-631', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Przychodnia Polskiej Fundacji Gastroenterologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'University Hospital "Clinico Lozano Blesa" of Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Alessandro Repici, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Hospital IRCCS, Rozzano-Milan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odin Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Meditrial Europe Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}