Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-28 @ 4:58 AM
Study NCT ID:
NCT06281392
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2023-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2024-02-25', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Per lesion" dysplasia detection rate (DDR)', 'timeFrame': 'Immediately after the procedure', 'description': 'Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI in patients with long-standing Inflammatory bowel disease who undergo surveillance colonoscopy'}, {'measure': '"Per patient" dysplasia detection rate (DDR)', 'timeFrame': 'Immediately after the procedure', 'description': 'Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Inflammatory bowel disease included in the study detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI'}], 'secondaryOutcomes': [{'measure': 'Duration of endoscopic examination', 'timeFrame': 'Immediately after the procedure', 'description': 'Median (IQR) examination time (in minutes) (including total, insertion, and withdrawal time) required by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'Virtual chromoendoscopy', 'NBI', 'CADe', 'Dysplasia'], 'conditions': ['Inflammatory Bowel Diseases', 'Dysplasia']}, 'descriptionModule': {'briefSummary': 'Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Adults (age ≥18 years).\n* Patients with IBD meeting the following criteria:\n* Diagnosis of IBD confirmed by clinical and histological evidence.\n* Disease extent (Montreal classification): 1) For Ulcerative Colitis (UC), Extensive colitis (E3): involvement proximal to the splenic flexure; or, Left-sided colitis (E2): involvement distal to the splenic flexure. 2) For Crohn's Disease (CD): Colon-only involvement (L2); or, Ileocolonic involvement (L3).\n* Disease duration \\> 7 years.\n* Patients with concommitant Primary Sclerosing Cholangitis, regardless of the extent of colonic involvement and disease duration.\n* Written consent from the patient to undergo colonoscopy (signed informed consent).\n\nEXCLUSION CRITERIA:\n\n* Personal history of colorectal cancer (CRC).\n* Previous colectomy (partial or complete).\n* Coagulopathy preventing biopsy or polypectomy/mucosal resection.\n* Colonoscopy performed in the last 6 months.\n* Pregnant or lactating women.\n* Ulcerative colitis with involvement limited to the rectum or Proctitis (Montreal E1).\n* Inadequate colonic preparation due to uncleavable fecal residue during colonoscopy: Boston Bowel Preparation Scale (BBPS) = 0 or 1 in any colon segment.\n* Presence of inflammatory activity due to IBD on endoscopy:1) For UC: Endoscopic Mayo Score ≥ 2. 2) For CD: Simplified Endoscopic Activity Score (SES-CD) \\> 5.\n* Incomplete lower digestive endoscopy (failure to reach the cecum)."}, 'identificationModule': {'nctId': 'NCT06281392', 'briefTitle': 'Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study)', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}, 'officialTitle': 'Effect of an Artificial Intelligence System on the Detection of Dysplasia During Colonoscopy in Patients With Long-standing Inflammatory Bowel Disease: a Randomized Study (EIIDISIA Study)', 'orgStudyIdInfo': {'id': 'CEIm: 106/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colonoscopy assisted by CADe', 'interventionNames': ['Device: CADe system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Colonoscopy with NBI', 'interventionNames': ['Device: NBI']}], 'interventions': [{'name': 'CADe system', 'type': 'DEVICE', 'description': 'Colonoscopy assisted by an artificial intelligence system (CADe).', 'armGroupLabels': ['Colonoscopy assisted by CADe']}, {'name': 'NBI', 'type': 'DEVICE', 'description': 'Virtual colonoscopy assisted by NBI', 'armGroupLabels': ['Virtual Colonoscopy with NBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46017', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Antonio López-Serrano', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Antonio López-Serrano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Dr. Peset, Valencia (Spain)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valencia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Endoscopy Section', 'investigatorFullName': 'Antonio López-Serrano', 'investigatorAffiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}}}}