Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT06077435
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2023-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'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': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized Controlled Trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 915}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the effectiveness of AI systems in characterizing polyps with conventional histology', 'timeFrame': 'During procedure (5minutes)', 'description': "The endoscopist's ability to characterize lesions with and without AI will be assessed, and this assessment will be compared to histology"}, {'measure': 'Comparison of Adenoma Detection Rates (ADR) between colonoscopies assisted by Artificial Intelligence (AI) and conventional colonoscopies without AI', 'timeFrame': 'During procedure (up to 40 minutes)', 'description': 'The ADR is typically expressed as a percentage and is calculated using the following formula:Number of colonoscopies with adenoma detection/ Total number of colonoscopies\n\n×100.'}, {'measure': 'To assess and compare the costs associated with AI-assisted colonoscopy versus conventional colonoscopy.', 'timeFrame': 'During procedure (5minutes)', 'description': 'Each cost associated with each examination, whether using AI-assisted or conventional colonoscopy, will be recorded prospectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Polyp', 'Colon Lesion']}, 'descriptionModule': {'briefSummary': 'Purpose \\& Research Questions\n\nThe purpose of this study is to evaluate whether artificial intelligence (AI) improves the detection of polyps and whether the system can classify the type and severity of detected changes. The investigators will also assess if there are any differences between the various AI systems and whether the polyps that may be missed are benign or malignant.', 'detailedDescription': "Materials: Selection, Representativeness, and Grouping\n\nThe study is a randomized controlled clinical trial conducted at Västra Götaland region. Patients are randomized to receive either AI or conventional endoscopy, and each endoscopy unit has access to at least one AI device. Informed consent is obtained from patients before the examination.\n\nBefore the examination, patients are asked if they want to participate in the study. If the patient wishes to participate, informed consent is obtained. The endoscopist then draws a slip from an envelope, determining whether conventional colonoscopy or AI will be used. During conventional colonoscopy, the patient is examined according to routine practice. After the examination, a questionnaire is filled out, recording various findings from the examination. During AI examinations, the AI system is activated only during instrument withdrawal. The system identifies polyps and alerts the endoscopist. Additionally, two of the AI systems (GI-Genius, CADEYE) have the ability to characterize the detected polyps and provide an interpretation of whether the changes are benign or malignant. After the examination, a similar questionnaire is completed as in conventional colonoscopy.\n\nMethod: Data Collection\n\nBasic data will be recorded, including the reason for the examination, other illnesses, medications, demographic data such as gender, age, family history of cancer, and the time of the examination (morning or afternoon). During the examination, the following will be recorded: the number of polyps, macroscopic classification of polyps, AI system's characterization of the polyps, bowel cleansing quality, laxative method, medication during the examination, complications occurring during or after the examination. Withdrawal time is recorded, as well as the number of false-positive polyps and supplementation with histological data of polyps after review by the pathologist. All materials and costs associated with the examination are recorded.\n\nThree different AI systems will be used at the various hospital sites, namely EndoAid (Olympus), CADEYE (Fujinon), and GI-Genius (Medtronic). All units will randomize each examination to either AI or non-AI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 50 years\n* Elective colonoscopy\n\nExclusion Criteria:\n\n* Patient declines to participate in the study.\n* Age \\< 50 years\n* Unprepared bowel'}, 'identificationModule': {'nctId': 'NCT06077435', 'briefTitle': 'Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Comparative Analysis of AI Software and Conventional Colonoscopy for Enhanced Polyp Detection and Diagnosis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '981840'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CAD-EYE', 'description': 'AI system 1. Sealed envelopes in blocks of four were used for randomisation.', 'interventionNames': ['Device: AI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GI-GENIUS', 'description': 'AI system 2. Sealed envelopes in blocks of four were used for randomisation', 'interventionNames': ['Device: AI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endo-AID', 'description': 'AI system 3. Sealed envelopes in blocks of four were used for randomisation', 'interventionNames': ['Device: AI']}, {'type': 'NO_INTERVENTION', 'label': 'No AI', 'description': 'No AI. conventional examination. Sealed envelopes in blocks of four were used for randomisation'}], 'interventions': [{'name': 'AI', 'type': 'DEVICE', 'description': 'AI system', 'armGroupLabels': ['CAD-EYE', 'Endo-AID', 'GI-GENIUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'state': 'Gothenbburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jonas Varkey, MD, PhD', 'role': 'CONTACT', 'email': 'jonas.varkey@vgregion.se', 'phone': '0046764030388'}], 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Jonas Varkey, MD, PhD', 'role': 'CONTACT', 'email': 'jonas.varkey@vgregion.se', 'phone': '0046764030388'}], 'overallOfficials': [{'name': 'Per Hedenstrom, MD. Ph D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Senior Consultant, MD, PhD,', 'investigatorFullName': 'Jonas Varkey', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}