Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-30 @ 4:52 PM
Study NCT ID:
NCT01288833
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2011-02-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tonya.kaltenbach@va.gov', 'phone': '415-221-4810', 'title': 'Dr. Tonya Kaltenbach', 'phoneExt': '94121', 'organization': 'San Francisco VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Close Focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis\n\nClose focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.', 'otherNumAtRisk': 277, 'otherNumAffected': 0, 'seriousNumAtRisk': 277, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis', 'otherNumAtRisk': 281, 'otherNumAffected': 0, 'seriousNumAtRisk': 281, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}, {'units': 'Polyps analyzed', 'counts': [{'value': '530', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Close Focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis\n\nClose focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.'}, {'id': 'OG001', 'title': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '71.3', 'upperLimit': '78.9'}, {'value': '63.1', 'groupId': 'OG001', 'lowerLimit': '58.5', 'upperLimit': '67.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of procedure', 'description': 'Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps.', 'unitOfMeasure': 'Percent of accurate HC predictions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Polyps analyzed', 'denomUnitsSelected': 'Polyps analyzed', 'populationDescription': 'We analyzed all diminutive sized polyps to assess the number of polyps that endoscopists were able to make an accurate high confidence optical diagnosis. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (non-neoplasia) in the NICE classification and no features associated with the other histology.'}, {'type': 'SECONDARY', 'title': 'Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Close Focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis\n\nClose focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.'}, {'id': 'OG001', 'title': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of procedure', 'description': 'Measure the cost of colonoscopy with macroscopic histopathologic diagnosis of colorectal lesions compared to colonoscopy with conventional microscopic histopathologic diagnosis, on the lesions that were managed based on an accurate endoscopic diagnosis.\n\nA reduction in pathology specimens may improve the efficiency of the procedure and has direct pathology cost savings (as well as indirect savings, which were not measured).', 'unitOfMeasure': 'Specimen bottles that could be omitted', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnostic Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}, {'units': 'Polyps analyzed', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Close Focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis\n\nClose focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.'}, {'id': 'OG001', 'title': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis'}], 'classes': [{'title': 'Accuracy', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '91.3'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '82.8', 'upperLimit': '90.5'}]}]}, {'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.3'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '90.8', 'upperLimit': '97.6'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '80'}, {'value': '75.7', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': '82.5'}]}]}, {'title': 'PPV', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '80.5', 'upperLimit': '88.8'}, {'value': '84.4', 'groupId': 'OG001', 'lowerLimit': '78.7', 'upperLimit': '89.0'}]}]}, {'title': 'NPV', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '91.8', 'upperLimit': '98.8'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '96.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of procedure', 'description': 'Compare the diagnostic characteristics (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features.\n\nAccuracy: number of endoscopic predictions of adenomatous polyps histologically confirmed to be adenomatous/number of predicted hyperplastic polyps confirmed to be hyperplastic out of all polyps Sensitivity: number of endoscopic predictions (optical diagnosis) of adenomatous (neoplastic) polyps out of all histologically confirmed polyps Specificity: number of endoscopic predictions of hyperplastic (non-neoplastic) polyps out of all histologically confirmed polyps PPV: number of histologically confirmed adenomatous polyps out of all endoscopic predictions of adenomatous polyps NPV: number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps Note: a patient may have multiple polyps', 'unitOfMeasure': 'percentage of high confidence prediction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Polyps analyzed', 'denomUnitsSelected': 'Polyps analyzed', 'populationDescription': '975 total polyps were found with high confidence predictions made on 774 of them.We assessed diagnostic performance of the high confidence predictions. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology.'}, {'type': 'SECONDARY', 'title': 'Accuracy of Predicted Versus Actual Surveillance Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Close Focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis\n\nClose focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.'}, {'id': 'OG001', 'title': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis'}], 'classes': [{'title': 'Predicted (optical diagnosis)', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}]}, {'title': 'Actual (histopathological diagnosis)', 'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of procedure', 'description': 'Compared the accuracy of predicted versus actual surveillance colonoscopy interval recommendations by determining number of patients with correct surveillance interval recommendation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Learning Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}, {'units': 'Diminutive polyps', 'counts': [{'value': '530', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Close Focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis\n\nClose focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.'}, {'id': 'OG001', 'title': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis'}], 'classes': [{'title': 'First half', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '98.6'}, {'value': '88.0', 'groupId': 'OG001', 'lowerLimit': '75.7', 'upperLimit': '95.5'}]}]}, {'title': 'Second half', 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '99.6'}, {'value': '95.8', 'groupId': 'OG001', 'lowerLimit': '88.3', 'upperLimit': '99.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of procedure.', 'description': 'Examine the impact of a learning curve (i.e. NPV of high confidence at each of endoscopist\'s first 50% of exams versus last 50% exams to endoscopically predict polyp histology). NPV is defined as "number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps.', 'unitOfMeasure': 'percentage of high confidence prediction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Diminutive polyps', 'denomUnitsSelected': 'Diminutive polyps', 'populationDescription': '975 total polyps were found and we were able to make high confidence predictions on 774 of them.'}, {'type': 'POST_HOC', 'title': 'Surveillance Colonoscopy Advanced Pathology Findings', 'timeFrame': '5 to 10 years after colonoscopy', 'description': 'Compare the advanced pathology and colon cancer incidence at surveillance colonoscopy of the groups who underwent high definition narrow band imaging colonoscopy with and without close focus features, and more specifically who underwent macroscopic versus microscopic polyp management. This applies if we bring the patient back after 5 years, we have not collected the data yet.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Close Focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis\n\nClose focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.'}, {'id': 'FG001', 'title': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '277'}, {'groupId': 'FG001', 'numSubjects': '281'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '277'}, {'groupId': 'FG001', 'numSubjects': '281'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '558', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Close Focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis\n\nClose focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.'}, {'id': 'BG001', 'title': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '62.4', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Indication', 'classes': [{'categories': [{'title': 'Screening', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Surveillance', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}, {'title': 'Symptoms', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 558}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2011-02-01', 'resultsFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-28', 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups.', 'timeFrame': 'At the time of procedure', 'description': 'Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps.'}], 'secondaryOutcomes': [{'measure': 'Cost', 'timeFrame': 'At the time of procedure', 'description': 'Measure the cost of colonoscopy with macroscopic histopathologic diagnosis of colorectal lesions compared to colonoscopy with conventional microscopic histopathologic diagnosis, on the lesions that were managed based on an accurate endoscopic diagnosis.\n\nA reduction in pathology specimens may improve the efficiency of the procedure and has direct pathology cost savings (as well as indirect savings, which were not measured).'}, {'measure': 'Diagnostic Characteristics', 'timeFrame': 'At time of procedure', 'description': 'Compare the diagnostic characteristics (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features.\n\nAccuracy: number of endoscopic predictions of adenomatous polyps histologically confirmed to be adenomatous/number of predicted hyperplastic polyps confirmed to be hyperplastic out of all polyps Sensitivity: number of endoscopic predictions (optical diagnosis) of adenomatous (neoplastic) polyps out of all histologically confirmed polyps Specificity: number of endoscopic predictions of hyperplastic (non-neoplastic) polyps out of all histologically confirmed polyps PPV: number of histologically confirmed adenomatous polyps out of all endoscopic predictions of adenomatous polyps NPV: number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps Note: a patient may have multiple polyps'}, {'measure': 'Accuracy of Predicted Versus Actual Surveillance Intervals', 'timeFrame': 'At the time of procedure', 'description': 'Compared the accuracy of predicted versus actual surveillance colonoscopy interval recommendations by determining number of patients with correct surveillance interval recommendation.'}, {'measure': 'Learning Curve', 'timeFrame': 'At time of procedure.', 'description': 'Examine the impact of a learning curve (i.e. NPV of high confidence at each of endoscopist\'s first 50% of exams versus last 50% exams to endoscopically predict polyp histology). NPV is defined as "number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Diagnostic Imaging', 'Colorectal Neoplasm', 'Primary Prevention', 'Cost and Cost Analysis', 'Endoscopy'], 'conditions': ['Colorectal Neoplasm', 'Colonic Polyps']}, 'referencesModule': {'references': [{'pmid': '18061178', 'type': 'BACKGROUND', 'citation': 'Kaltenbach T, Sano Y, Friedland S, Soetikno R; American Gastroenterological Association. American Gastroenterological Association (AGA) Institute technology assessment on image-enhanced endoscopy. Gastroenterology. 2008 Jan;134(1):327-40. doi: 10.1053/j.gastro.2007.10.062. Epub 2007 Oct 30.'}, {'pmid': '16012987', 'type': 'BACKGROUND', 'citation': 'Muto M, Katada C, Sano Y, Yoshida S. Narrow band imaging: a new diagnostic approach to visualize angiogenesis in superficial neoplasia. Clin Gastroenterol Hepatol. 2005 Jul;3(7 Suppl 1):S16-20. doi: 10.1016/s1542-3565(05)00262-4.'}, {'pmid': '19187781', 'type': 'BACKGROUND', 'citation': 'Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.'}, {'pmid': '20561618', 'type': 'BACKGROUND', 'citation': 'Raghavendra M, Hewett DG, Rex DK. Differentiating adenomas from hyperplastic colorectal polyps: narrow-band imaging can be learned in 20 minutes. Gastrointest Endosc. 2010 Sep;72(3):572-6. doi: 10.1016/j.gie.2010.03.1124. Epub 2010 Jun 19.'}, {'pmid': '19584829', 'type': 'BACKGROUND', 'citation': 'Rastogi A, Keighley J, Singh V, Callahan P, Bansal A, Wani S, Sharma P. High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study. Am J Gastroenterol. 2009 Oct;104(10):2422-30. doi: 10.1038/ajg.2009.403. Epub 2009 Jul 7.'}, {'pmid': '19910250', 'type': 'BACKGROUND', 'citation': 'Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.'}, {'pmid': '19922926', 'type': 'BACKGROUND', 'citation': 'Rex DK, Fennerty MB, Sharma P, Kaltenbach T, Soetikno R. Bringing new endoscopic imaging technology into everyday practice: what is the role of professional GI societies? Polyp imaging as a template for moving endoscopic innovation forward to answer key clinical questions. Gastrointest Endosc. 2010 Jan;71(1):142-6. doi: 10.1016/j.gie.2009.09.011. Epub 2009 Nov 17. No abstract available.'}, {'pmid': '29174789', 'type': 'DERIVED', 'citation': 'von Renteln D, Kaltenbach T, Rastogi A, Anderson JC, Rosch T, Soetikno R, Pohl H. Simplifying Resect and Discard Strategies for Real-Time Assessment of Diminutive Colorectal Polyps. Clin Gastroenterol Hepatol. 2018 May;16(5):706-714. doi: 10.1016/j.cgh.2017.11.036. Epub 2017 Nov 23.'}, {'pmid': '25387891', 'type': 'DERIVED', 'citation': 'Kaltenbach T, Rastogi A, Rouse RV, McQuaid KR, Sato T, Bansal A, Kosek JC, Soetikno R. Real-time optical diagnosis for diminutive colorectal polyps using narrow-band imaging: the VALID randomised clinical trial. Gut. 2015 Oct;64(10):1569-77. doi: 10.1136/gutjnl-2014-307742. Epub 2014 Nov 11.'}, {'pmid': '25264764', 'type': 'DERIVED', 'citation': 'McGill SK, Soetikno R, Rastogi A, Rouse RV, Sato T, Bansal A, McQuaid K, Kaltenbach T. Endoscopists can sustain high performance for the optical diagnosis of colorectal polyps following standardized and continued training. Endoscopy. 2015 Mar;47(3):200-6. doi: 10.1055/s-0034-1378096. Epub 2014 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that high definition colonoscopy with close focus narrow band imaging features has a high diagnostic accuracy for colorectal polyp histology, and can replace formal pathologic assessment in cases of high diagnostic confidence.', 'detailedDescription': 'A recent single arm prospective cohort study suggested that high definition colonoscopy with narrow band imaging is an acceptable strategy to diagnose polyp histology and determine future surveillance intervals. Endoscopic proficiency in macroscopic features to differentiate polyp histology can be attained in a relatively short time period. A new high definition colonoscope with close focus narrow band imaging features may further improve diagnostic accuracy for polyp differentiation, and can replace formal pathologic assessment in cases of high diagnostic confidence.\n\nPrimary Aim: Compare the diagnostic accuracy of high definition narrow band imaging colonoscopy with and without close focus features for the macroscopic differentiation of neoplastic and non-neoplastic colorectal lesions using histopathologic diagnosis as the reference standard.\n\nSecondary Aims: Compare diagnostic characteristics of the colonoscopes, measure concordance of high confidence and accuracy, compare accuracy of predicted versus actual surveillance interval recommendations, perform a cost-effective analysis of endoscopic versus pathologic diagnoses, and measure complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients referred for routine colonoscopy\n\nExclusion Criteria:\n\n* Known inflammatory bowel disease\n* Personal or family history of polyposis or non-polyposis syndrome\n* Presentation for emergency endoscopy\n* Inability to remove polyp due to coagulopathy or thrombocytopenia\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01288833', 'acronym': 'VALID', 'briefTitle': 'Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study', 'organization': {'class': 'FED', 'fullName': 'VA Palo Alto Health Care System'}, 'officialTitle': 'Real Time Colorectal Polyp Diagnosis in Colorectal Cancer Screening Using Close Focus High Definition Narrow Band Imaging Colonoscopy Compared to Conventional Histopathology Diagnosis - the VALID (Veterans Affairs Lesion Interpretation and Diagnosis) Colonoscopy Study', 'orgStudyIdInfo': {'id': 'VALID PA19624'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Close focus HD NBI Colonoscopy System', 'description': 'Use of close focus to make optical diagnosis', 'interventionNames': ['Device: Close focus HD NBI Colonoscopy System']}, {'type': 'NO_INTERVENTION', 'label': 'Current HD NBI Colonoscopy System', 'description': 'Use of standard focus for optical diagnosis'}], 'interventions': [{'name': 'Close focus HD NBI Colonoscopy System', 'type': 'DEVICE', 'description': 'Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.', 'armGroupLabels': ['Close focus HD NBI Colonoscopy System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Palo Alto', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Veterans Affairs Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Tonya Kaltenbach, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veterans Affairs Palo Alto'}, {'name': 'Roy Soetikno, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veterans Affairs Palo Alto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Palo Alto Health Care System', 'class': 'FED'}, 'collaborators': [{'name': 'Kansas City Veteran Affairs Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Roy Soetikno', 'investigatorAffiliation': 'VA Palo Alto Health Care System'}}}}