Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 1:22 PM
Study NCT ID:
NCT06992856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 531}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of straight passage through the sigmoid colon without loop formation', 'timeFrame': 'immediately after the procedure'}], 'secondaryOutcomes': [{'measure': 'Cecal intubation rate', 'timeFrame': 'immediately after the procedure'}, {'measure': 'Cecal intubation time', 'timeFrame': 'immediately after the procedure'}, {'measure': 'Time of insertion to cecum', 'timeFrame': 'immediately after the procedure'}, {'measure': 'Colonoscope insertion failure rate', 'timeFrame': 'immediately after the procedure'}, {'measure': 'Adenoma detection rate', 'timeFrame': '2 weeks after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscope passage', 'left colon water exchange', 'cap-assisted', 'without loop formation'], 'conditions': ['Colonoscope Passage']}, 'descriptionModule': {'briefSummary': 'A prospective, single-center, single-blind, randomized controlled study to compare the proportion of straight passage through the sigmoid colon without loop formation between conventional colonoscope passage, left colon water exchange colonoscope passage, and cap-assisted left colon water exchange colonoscope passage through the sigmoid colon', 'detailedDescription': '1. Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.\n2. Randomize patients into 3 interventional groups based on R script (version 4.4.1), including (1) Group 1: Conventional colonoscope passage, (2) Group 2: left colon water exchange colonoscope passage, (3) Group 3: cap-assisted left colon water exchange colonoscope passage.\n3. Collecting variables which consist of primary and secodary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-80 years\n* sedation colonoscopy\n\nExclusion Criteria:\n\n* History of colorectal surgery\n* Clinical suspicion of, or pathologically confirmed, colorectal cancer\n* Presence of any "alarm" symptom or sign-hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination\n* Pregnancy or lactation\n* Known or suspected gastrointestinal obstruction\n* Diagnosed inflammatory bowel disease\n* Use of antiplatelet or anticoagulant therapy (e.g., aspirin, warfarin) within 7 days before colonoscopy or any documented coagulation disorder\n* Current enrolment in another clinical study or participation in any clinical trial within the previous 60 days\n* Requirement for emergency colonoscopy\n* Any other condition that, in the investigators\' judgment, renders the patient unsuitable for inclusion in the study'}, 'identificationModule': {'nctId': 'NCT06992856', 'briefTitle': 'The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation', 'orgStudyIdInfo': {'id': '2025K235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional colonoscope passage', 'description': 'Use conventional colonoscope passage through the sigmoid colon', 'interventionNames': ['Procedure: Conventional colonoscope passage']}, {'type': 'EXPERIMENTAL', 'label': 'left colon water exchange colonoscope passage', 'description': 'Use left colon water exchange colonoscope passage through the sigmoid colon', 'interventionNames': ['Procedure: left colon water exchange colonoscope passage']}, {'type': 'EXPERIMENTAL', 'label': 'Cap-assisted left colon water exchange colonoscope passage', 'description': 'Use Cap-assisted left colon water exchange colonoscope passage through the sigmoid colon', 'interventionNames': ['Procedure: cap-assisted left colon water exchange colonoscope passage']}], 'interventions': [{'name': 'Conventional colonoscope passage', 'type': 'PROCEDURE', 'description': 'Use conventional colonoscope passage through the sigmoid colon', 'armGroupLabels': ['conventional colonoscope passage']}, {'name': 'left colon water exchange colonoscope passage', 'type': 'PROCEDURE', 'description': 'Use left colon water exchange colonoscope passage through the sigmoid colon', 'armGroupLabels': ['left colon water exchange colonoscope passage']}, {'name': 'cap-assisted left colon water exchange colonoscope passage', 'type': 'PROCEDURE', 'description': 'Use cap-assisted left colon water exchange colonoscope passage through sigmoid colon', 'armGroupLabels': ['Cap-assisted left colon water exchange colonoscope passage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Danian Ji, M.D.', 'role': 'CONTACT', 'email': 'arctg4@163.com', 'phone': '+86-18019094606'}, {'name': 'Zhiyu Dong, M.D.', 'role': 'CONTACT', 'email': '18817870866@163.com', 'phone': '+86-18817870866'}], 'facility': 'Huadong hospital affiliated to Fudan university', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Danian Ji, M.D.', 'role': 'CONTACT', 'email': 'arctg4@163.com', 'phone': '+86-18019094606'}, {'name': 'Zhiyu Dong, M.D.', 'role': 'CONTACT', 'email': '18817870866@163.com', 'phone': '+86-18817870866'}], 'overallOfficials': [{'name': 'Danian Ji, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Huadong Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '1 year after completion of this study', 'ipdSharing': 'YES', 'description': 'All collected IPD', 'accessCriteria': 'All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhijun Bao', 'investigatorAffiliation': 'Fudan University'}}}}