Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-24 @ 11:25 PM
Study NCT ID:
NCT05322993
Status:
UNKNOWN
Last Update Posted:
2024-02-01
First Post:
2022-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Endoscopists will perform colonoscopies in three consecutive phases; 1. without artificial intelligence (AI), 2. with AI, 3. without (AI).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polyp detection rate (PDR) with and without artificial intelligence (AI)', 'timeFrame': '18 months', 'description': 'Evaluate the PDR with and without the use of GI Genus artificial intelligence'}, {'measure': 'PDR after the use of AI, is there a learning effect?', 'timeFrame': '18 months', 'description': 'Evaluate if there is an improved PDR after the use of AI'}], 'secondaryOutcomes': [{'measure': 'Withdrawal time', 'timeFrame': '18 months', 'description': 'To evaluate if the withdrawal time is influenced by the use of artificial intelligence'}, {'measure': 'Complications', 'timeFrame': '24 months', 'description': 'To evaluate if there are more registered complications with the use of AI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Artificial intelligence', 'Polyp detection'], 'conditions': ['Colonic Polyp']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.sthf.no/gastronet', 'label': 'Gastronet, the national quality register of colonoscopies'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate if the use of artificial intelligence (AI) in colonoscopy improves the polyp detection rate, and if the use of AI has a learning effect.', 'detailedDescription': "The endoscopists will use GI Genius from Medtronic, a device that uses artificial intelligence (AI) based on machine learning to detect polyps in the colon in real time during colonoscopy. The device interprets the endoscopy pictures and superimposes possible polyps with frames.\n\nThe patients will be included in regular outpatient clinics in Western Norway. The endoscopists will be divided into groups depending on their experience. The endoscopists will perform colonoscopies in three phases; (1) before the use of AI, (2) during the use of AI and (3) after the use of AI. The investigators will then evaluate the polyp detection rate (PDR) in the three phases to see if AI increases PDR, and if there is a learning effect on PDR after the use of AI. The investigators will also evaluate if there is a difference in the learning-effect from AI-use depending on if the endoscopist is experienced or inexperienced.\n\nThe PDR's are registered as part of Norway's national quality register of colonoscopy, Gastronet. The data registered in Gastronet can also help the investigators evaluate other outcomes such as withdrawal time, bowel preparation, patient reported pain, patient satisfaction and complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients coming to outpatient clinics to perform colonoscopies\n\nExclusion Criteria:\n\n* Total colectomy\n* Reservation against registration in Gastronet, the national quality register for colonoscopy in Norway'}, 'identificationModule': {'nctId': 'NCT05322993', 'briefTitle': 'Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Haraldsplass Deaconess Hospital'}, 'officialTitle': 'Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy', 'orgStudyIdInfo': {'id': 'REK 275068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'With artificial intelligence (AI)', 'description': 'Use of GI Genius artificial intelligence device during colonoscopy.', 'interventionNames': ['Device: GI Genius']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Without artificial intelligence', 'description': 'Use of standard colonoscopy equipment without GI Genius.', 'interventionNames': ['Device: Standard white light colonoscope']}], 'interventions': [{'name': 'GI Genius', 'type': 'DEVICE', 'description': 'The use of artificial intelligence during colonoscopy to improve polyp detection.', 'armGroupLabels': ['With artificial intelligence (AI)']}, {'name': 'Standard white light colonoscope', 'type': 'DEVICE', 'description': 'Standard colonoscopy.', 'armGroupLabels': ['Without artificial intelligence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5009', 'city': 'Bergen', 'state': 'Vestland', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Tom André Pedersen, MD', 'role': 'CONTACT', 'email': 'tom.andre.pedersen@haraldsplass.no', 'phone': '95812371', 'phoneExt': '+47'}, {'name': 'Abid Aziz, MD', 'role': 'CONTACT', 'email': 'abid.aziz@haraldsplass.no', 'phone': '92049192', 'phoneExt': '+47'}], 'facility': 'Haraldsplass Deaconess Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '5021', 'city': 'Bergen', 'state': 'Vestland', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Roald F. Havre, Professor', 'role': 'CONTACT', 'email': 'roald.flesland.havre@helse-bergen.no', 'phone': '90842938', 'phoneExt': '+47'}, {'name': 'Trond Engjom, PhD', 'role': 'CONTACT', 'email': 'trond.engjom@helse-bergen.no', 'phone': '92049852', 'phoneExt': '+47'}], 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '5068', 'city': 'Bergen', 'state': 'Vestland', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Georg G. Dimcevski, Professor', 'role': 'CONTACT', 'email': 'georg.dimcevski@gmail.com', 'phone': '46667907', 'phoneExt': '+47'}, {'name': 'Skjalg Klomstad, MD', 'role': 'CONTACT', 'email': 'sklomstad@gmail.com', 'phone': '90167688', 'phoneExt': '+47'}], 'facility': 'Kanalspesialistene AS', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Tom André Pedersen, MD', 'role': 'CONTACT', 'email': 'tom_andre_pedersen@haraldsplass.no', 'phone': '95812371', 'phoneExt': '+47'}, {'name': 'Roald F. Havre, Professor', 'role': 'CONTACT', 'email': 'roald.flesland.havre@helse-bergen.no', 'phone': '90842938', 'phoneExt': '+47'}], 'overallOfficials': [{'name': 'Roald F. Havre, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helse Bergen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no specific plan to share IPD with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haraldsplass Deaconess Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'European Society of Gastrointestinal Endoscopy', 'class': 'OTHER'}, {'name': 'Kanalspesialistene AS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}