Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT07076966
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2024-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Adenoma Detection Rate in 3D vs. 2D Surveillance Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3D colonoscopy versus standard 2D colonoscopy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2025-07-19', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Flat-ADR', 'timeFrame': '30 minutes', 'description': 'detection rate of flat adenoma'}, {'measure': 'Proximal ADR', 'timeFrame': '30 minutes', 'description': 'detection rate of adenoma at proximal colon'}, {'measure': 'Distal ADR', 'timeFrame': '30 minutes', 'description': 'detection rate of adenoma at distal colon'}, {'measure': 'SSLDR', 'timeFrame': '30 minutes', 'description': 'detection rate of sessile serrated lesion'}, {'measure': 'AADR', 'timeFrame': '30 minutes', 'description': 'detection rate of advanced adenoma'}, {'measure': 'Detection of of adenoma with various size', 'timeFrame': '30 minutes'}, {'measure': 'Polyp detection rate', 'timeFrame': '30 minutes'}, {'measure': 'Adenoma number per colonoscopy,', 'timeFrame': '30 minutes'}, {'measure': 'Polyp number per colonoscopy', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'adenoma detection rate', '3D', 'surveillance colonoscopy'], 'conditions': ['Colonoscopy', 'Adenoma Detection Rate', 'Three Dimensional', 'Colon Polyps and Adenomas']}, 'descriptionModule': {'briefSummary': "There is substantial evidence confirming that identifying and removing colorectal adenomas during colonoscopy helps prevent the development of colorectal cancer. Among the quality indicators for colonoscopy, adenoma detection rate (ADR) is the most important, as it is closely related to the patient's future risk of colorectal cancer. Recent studies have further demonstrated that improving ADR can reduce future mortality from colorectal cancer. Notably, non-polypoid lesions (such as flat or depressed lesions) are more likely to be missed during traditional colonoscopy, making these lesions a leading cause of post-colonoscopy interval colorectal cancer.\n\nIn a prospective trial conducted by our team comparing the ADR of 3D colonoscopy with standard 2D colonoscopy, we found that 3D colonoscopy significantly improved overall ADR and the detection rate of non-polypoid adenomas.\n\nAccording to current international guidelines, after an index colonoscopy, patients are recommended to undergo surveillance colonoscopy 1 to 10 years later, depending on their findings at index colonoscopy. Since these patients represent the majority in clinical practice, increasing the ADR during surveillance colonoscopy not only allows for more precise recommendations for the timing of the next colonoscopy but also effectively reduces the risk of post-colonoscopy colorectal cancer (PCCRC).\n\nTherefore, this multicenter, prospective, randomized trial aims to compare the clinical performance of 3D colonoscopy and standard 2D colonoscopy in the context of surveillance colonoscopy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are 40 years of older\n* Subjects who receive colonoscopy and polypectomy more the 1 year\n* Subjects who need surveillance colonoscopy\n\nExclusion Criteria:\n\n* Contraindication for colonoscopy\n* Subjects with familiar or hereditary polyposis\n* Subjects with history of colectomy\n* Inadequate bowel cleansing level\n* Subjects with inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT07076966', 'briefTitle': 'Comparison of Adenoma Detection Rate in 3D vs. 2D Surveillance Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Surveillance Colonoscopy: A Multi-center, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202311019DIPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D colonoscopy', 'interventionNames': ['Device: 3D device']}, {'type': 'NO_INTERVENTION', 'label': '2D colonoscopy'}], 'interventions': [{'name': '3D device', 'type': 'DEVICE', 'description': 'Use 3D machine to generate the 3D image', 'armGroupLabels': ['3D colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hsinchu', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsuan-Ho Lin, MD, MSc', 'role': 'CONTACT', 'email': 'tostart21@gmail.com', 'phone': '886-2-23123456'}], 'facility': 'National Taiwan University Hospital, Hsinchu Branch', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}, {'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hao-Che Chang, MD', 'role': 'CONTACT', 'email': 'andrewhcchang@gmail.com', 'phone': '886-2-23123456'}], 'facility': 'National Taiwan University Cancer Center', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Li-Chun Chang, MD. PhD.', 'role': 'CONTACT', 'email': 'lichunchang@ntu.edu.tw', 'phone': '886-9-72-651-258'}, {'name': 'Li-Chun Chang, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Li-Chun Chang, MD. PhD.', 'role': 'CONTACT', 'email': 'lichunchang@ntu.edu.tw', 'phone': '886-9-72-651-258'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician, Department of Internal Medicine', 'investigatorFullName': 'Statistical Center, NTUHCTC', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}