Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-28 @ 9:21 PM
Study NCT ID:
NCT07097350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 524}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-13', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adenoma detection rate', 'timeFrame': '2 weeks after the procedure'}], 'secondaryOutcomes': [{'measure': 'sessile serrated lesion detection rate', 'timeFrame': '2 weeks after the procedure'}, {'measure': 'advanced adenoma detection rate', 'timeFrame': '2 weeks after the procedure'}, {'measure': 'polyp detection rate', 'timeFrame': '2 weeks after the procedure'}, {'measure': 'Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）rate', 'timeFrame': 'immediately after the procedure', 'description': 'CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis'}, {'measure': 'Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）rate', 'timeFrame': '2 weeks after the procedure', 'description': 'CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).'}, {'measure': 'perforation rate', 'timeFrame': 'immediately after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transparent cap', 'computer-aided detection', 'adenoma detection rate'], 'conditions': ['Colorectal Adenoma']}, 'descriptionModule': {'briefSummary': 'A prospective, single-center, single-blind, randomized controlled study to compare the effectiveness of transparent cap-assisted colonoscopy combined with computer-aided detection and computer-aided detection alone in improvement of adenoma detection rate', 'detailedDescription': '1. Patients are undergone screening or surveillance colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.\n2. Randomize into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: computer-aided detection alone and (2) Group 2: transparent cap-assisted computer-aided detection.\n3. Collecting variables which consist of primary and secodary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 45-75 years\n\nExclusion Criteria:\n\n* Patients scheduled for therapeutic colonoscopy as postoperative surveillance after colorectal surgery, post-polypectomy follow-up, or treatment of histologically confirmed polyps\n* Patients with highly suspected or pathologically confirmed colorectal cancer\n* Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination)\n* Pregnant or breastfeeding women\n* Patients with gastrointestinal obstruction\n* Patients with inflammatory bowel disease, familial adenomatous polyposis, or serrated polyposis syndrome\n* Patients who have taken anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy or who have coagulation disorders\n* Patients currently enrolled in another clinical study or who participated in any clinical trial within the past 60 days\n* Insertion failure for any reason (e.g., scope cannot pass an obstruction, patient cannot tolerate the procedure) or colonoscopy not reaching the cecum\n* A Boston Bowel Preparation Scale (BBPS) score \\< 6 at scope insertion (inadequate preparation requiring repeat bowel cleansing)\n* Use of non-guideline-recommended bowel preparation agents\n* Patients undergoing emergency colonoscopy'}, 'identificationModule': {'nctId': 'NCT07097350', 'briefTitle': 'Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Study on the Effect of Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas', 'orgStudyIdInfo': {'id': '2025K239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'computer-aided detection alone', 'description': 'colonoscopy with computer-aided detection alone', 'interventionNames': ['Device: computer-aided detection alone']}, {'type': 'EXPERIMENTAL', 'label': 'transparent cap-assisted colonoscopy combined with computer-aided detection', 'description': 'transparent cap-assisted colonoscopy combined with computer-aided detection', 'interventionNames': ['Device: transparent cap-assisted colonoscopy combined with computer-aided detection']}], 'interventions': [{'name': 'computer-aided detection alone', 'type': 'DEVICE', 'description': 'colonoscopy with computer-aided detection', 'armGroupLabels': ['computer-aided detection alone']}, {'name': 'transparent cap-assisted colonoscopy combined with computer-aided detection', 'type': 'DEVICE', 'description': 'transparent cap-assisted colonoscopy combined with computer-aided detection', 'armGroupLabels': ['transparent cap-assisted colonoscopy combined with computer-aided detection']}]}, '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, 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'}}}}