Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT03833492
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2019-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-02-04', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete resection rate', 'timeFrame': '7 days', 'description': 'complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.'}, {'measure': 'En bloc resection rate', 'timeFrame': 'immediately', 'description': 'En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.'}], 'secondaryOutcomes': [{'measure': 'Adverse event rate', 'timeFrame': '14 days', 'description': 'Including bleeding and perforation , etc.'}, {'measure': 'Procedure time', 'timeFrame': '24 hours', 'description': 'Time to execute the program'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Polyps']}, 'referencesModule': {'references': [{'pmid': '32967616', 'type': 'DERIVED', 'citation': 'Zhang Z, Xia Y, Cui H, Yuan X, Wang C, Xie J, Tong Y, Wang W, Xu L. Underwater versus conventional endoscopic mucosal resection for small size non-pedunculated colorectal polyps: a randomized controlled trial : (UEMR vs. CEMR for small size non-pedunculated colorectal polyps). BMC Gastroenterol. 2020 Sep 23;20(1):311. doi: 10.1186/s12876-020-01457-y.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients age between 18-75 years old with non-pedunculated colonic polyps (measuring between 4 and 9mm), who willing to participate in this study.\n\nExclusion Criteria:\n\n1. pregnancy,\n2. inflammatory bowel disease,\n3. familial polyposis\n4. the use of anticoagulant therapy or antiplatelet therapy\n5. the absence of informed patient consent.\n6. Polyps showing signs of deep submucosal invasion'}, 'identificationModule': {'nctId': 'NCT03833492', 'briefTitle': 'UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Ningbo No. 1 Hospital'}, 'officialTitle': 'Efficacy and Safety of Underwater vs. Conventional Endoscopic Mucosal Resection for the Treatment of Diminutive Non-pedunculated Colorectal Polyps：A Multicenter Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'UEMR-1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Underwater EMR', 'description': 'The patients who are randomized to the " Underwater EMR" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.', 'interventionNames': ['Behavioral: Underwater EMR']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional EMR', 'description': 'The patients who are randomized to the " Traditional EMR" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.'}], 'interventions': [{'name': 'Underwater EMR', 'type': 'BEHAVIORAL', 'description': 'Polypectomy is performed under full water emersion without the use of submucosal injection.', 'armGroupLabels': ['Underwater EMR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315000', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '315000', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '315010', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ningbo first hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}