Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-01 @ 7:08 AM
Study NCT ID:
NCT02387593
Status:
UNKNOWN
Last Update Posted:
2015-03-13
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-03-24', 'releaseDate': '2016-02-23'}], 'estimatedResultsFirstSubmitDate': '2016-02-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': '30 minutes', 'description': 'Percentage of adenomas detected during colonoscopy'}, {'measure': 'Measurement of the polyp detection rate', 'timeFrame': '30 minutes', 'description': 'Percentage of polyps detected during colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Cecal intubation rate', 'timeFrame': '30 minutes', 'description': 'Percentage of cecal intubation'}, {'measure': 'ileal intubation rate', 'timeFrame': '10 minutes', 'description': 'Percentage of ileal intubation'}, {'measure': 'Difficulty performing polypectomy', 'timeFrame': '10 minutes', 'description': 'When the endoscopist requiring special maneuvers to perform polypectomy'}, {'measure': 'Complications during colonoscopy', 'timeFrame': 'One week', 'description': 'When patients require special handling during or immediately subsequent colonoscopy'}]}, 'conditionsModule': {'keywords': ['Adenoma', 'Colonoscopy', 'Screening'], 'conditions': ['Colorectal Canceer']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.\n\nThe benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.\n\nThe "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.\n\nThere is insufficient evidence of the usefulness of endocuf', 'detailedDescription': 'All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult patients,\n* Aged 18,\n* Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies\n\nExclusion Criteria:\n\n* Boston colonic preparation \\<5 points\n* Suspected Lynch syndrome or familial adenomatous polyposis (FAP)'}, 'identificationModule': {'nctId': 'NCT02387593', 'briefTitle': 'Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'END-1302-14/15-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'colonoscopy with endocuff', 'description': 'To the usual colonoscopy will place a endocuff at the tip of the colonoscope', 'interventionNames': ['Device: ENDOCUFF']}, {'type': 'NO_INTERVENTION', 'label': 'standard colonoscopy without endocuff', 'description': 'Routine colonoscopy without endocuff'}], 'interventions': [{'name': 'ENDOCUFF', 'type': 'DEVICE', 'description': 'One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline', 'armGroupLabels': ['colonoscopy with endocuff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'México', 'state': 'Tlalpan', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Rafael Barreto, MD', 'role': 'CONTACT', 'email': 'barretozu@yahoo.com', 'phone': '54870900', 'phoneExt': '2150'}], 'facility': 'Rafael Barreto', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}], 'centralContacts': [{'name': 'Rafael RB Barreto Zúñiga, MD', 'role': 'CONTACT', 'email': 'barretozu@yahoo.com', 'phone': '0155- 54870900', 'phoneExt': '2150'}, {'name': 'Rafael Rafael, MD', 'role': 'CONTACT', 'email': 'barretozu@yahoo.com', 'phone': '0155-54870900', 'phoneExt': '2150'}], 'overallOfficials': [{'name': 'Rafael Rafael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Endoscopy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attached to the Department of Endoscopy Medical Institute', 'investigatorFullName': 'Dr. Rafael Barreto Zúñiga', 'investigatorAffiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-02-23', 'type': 'RELEASE'}, {'date': '2016-03-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. Rafael Barreto Zúñiga, Associate Profesor of the Department of Gastrointestinal Endoscopy Medical Institute, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}