Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 10:48 PM
Study NCT ID:
NCT02352233
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2014-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retroview Colonoscope for the Evaluation of Colon Mucosa Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'biopsies, tissue from colonic mucosa: inflammatory, polyps'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-27', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of lesions', 'timeFrame': '3 months', 'description': 'number of lesions detected during the entire colonoscopy'}, {'measure': 'Endoscopic Treatment', 'timeFrame': '3 months', 'description': 'number of endoscopic therapeutic procedures in retro vision during colonoscopy'}], 'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '3 months', 'description': 'The safety was measured by the number of cases with bleeding or perforation'}, {'measure': 'Feasibility', 'timeFrame': '3 months', 'description': 'The feasibility was measured determining the number of cases that was possible to perform a retro view by segments in the colon.'}], 'secondaryOutcomes': [{'measure': 'Withdrawal colonoscopy phase', 'timeFrame': '3 months', 'description': 'withdrawal colonoscopy phase time measured in minutes (excluding time taking in minutes in case of therapeutics)'}, {'measure': 'Total procedure time', 'timeFrame': '3 months', 'description': 'Total procedure time including retro view and forward view in minutes (excluding time taking in minutes in case of therapeutics)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['retroview colonoscope', 'retroflexion colonoscopy', 'colonoscopy'], 'conditions': ['Colonic Diseases']}, 'referencesModule': {'references': [{'pmid': '20018280', 'type': 'BACKGROUND', 'citation': 'Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Colonoscopy is the "gold standard" technique for diagnosis and treatment of colonic lesions. Moreover, high definition colonoscopes (HD) associated to digital chromoendoscopy had shown better results regarding adenoma and polyps detection when compared to standard non HD scopes. However, evidence shows that during standard colonoscopy many lesions could be missed, including polyps, cancer and other kind of lesions. This could be correlated to many factors and recently reports show evidence that lesions behind the folds could be missed because the limitation of a forward view examination. Until know, a new auxiliary imaging device called "Third Eye Retroscope" had demonstrated more lesions detection during colonoscopy using a retro view, but with some limitations as absence of HD vision, the need of additional equipment and the fact the device occupies the accessory channel, limiting therapeutic efficiency. Recently a new HD colonoscope called "RETROVIEW" (PENTAX Medical) has been developed. It permits visualization of colonic mucosa in forward view, in retroflex view and allows for performance of diagnostic and therapeutics in a single colonoscope.', 'detailedDescription': 'Primary outcome:\n\nTo determine the safety and feasibility of the retro view during colonoscopy using RETROVIEW colonoscope. Safety was measured by the number of bleeding or perforation rates as adverse event during the procedure. Feasibility was measured by the number of cases that is possible to achieve a retroflexion in the colon Secondary outcome: withdrawal phase time and total procedure time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients undergoing for colonoscopy at the Instituto Ecuatoriano de Enfermedades Digestivas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing colonoscopy for colorectal neoplasia screening, for polyp surveillance, or for diagnostic workup including anemia, abdominal pain, constipation, abnormal imaging; and if they were able to understand and provide written consent for the procedure.\n\nExclusion Criteria:\n\n* age \\<18; pregnancy, included history of colon resection, known inflammatory bowel disease, polyposis syndrome, radiation therapy to abdomen or pelvis, suspicion of chronic stricture potentially precluding complete colonoscopy, presence of diverticulitis or toxic megacolon, hemophilia and concurrent enrollment in another clinical investigation.'}, 'identificationModule': {'nctId': 'NCT02352233', 'acronym': 'REVCOR', 'briefTitle': 'Retroview Colonoscope for the Evaluation of Colon Mucosa Study', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Ecuatoriano de Enfermedades Digestivas'}, 'officialTitle': 'Pentax Retroview Colonoscope for the Evaluation of Colon Mucosa in Forward and Retro Viewing: a Safety and Feasibility Pilot Study', 'orgStudyIdInfo': {'id': 'IECED 01-14-2014'}, 'secondaryIdInfos': [{'id': 'IECED 2014-01', 'type': 'OTHER', 'domain': 'IECED 2014-01'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'colonoscopy group', 'description': 'consecutive patients undergoing for colonoscopy for any formal indication. Patients were submitted to colonoscopy using RETROVIEW colonoscope', 'interventionNames': ['Procedure: RETROVIEW colonoscope']}], 'interventions': [{'name': 'RETROVIEW colonoscope', 'type': 'PROCEDURE', 'otherNames': ['Retro view colonoscopy', 'Retroflexion during colonoscopy'], 'description': 'withdrawal in retro vision and forward vision was performed by segments (right, transverse, left, sigmoid colon and rectum). Retroflexed therapeutics procedures were executed when needed.', 'armGroupLabels': ['colonoscopy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1301266', 'city': 'Guayaquil', 'state': 'Guayas', 'country': 'Ecuador', 'facility': 'Instituto Ecuatoriano de Enfermedades Digestivas', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}], 'overallOfficials': [{'name': 'Carlos Robles-Medranda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Ecuatoriano de Enfermedades Digestivas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}