Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT01044732
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2010-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Third Eye Retroscope Randomized Clinical Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D011127', 'term': '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': '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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhiggins@avantismedical.com', 'phone': '6508239216', 'title': 'Jack Higgins, MD - Chief Medical Officer', 'organization': 'Avantis Medical Systems'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'With mean subject age of 57.8 years, population was younger than in some studies, so polyp prevalence might be below average.'}}, 'adverseEventsModule': {'timeFrame': '24-72 hours post-procedure', 'description': 'Assessed through follow-up telephone interview', 'eventGroups': [{'id': 'EG000', 'title': 'Group A - SC Followed by TEC', 'description': 'Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)\n\nThird Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon', 'otherNumAtRisk': 184, 'otherNumAffected': 0, 'seriousNumAtRisk': 184, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B - TEC Followed by SC', 'description': 'Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)\n\nThird Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon', 'otherNumAtRisk': 188, 'otherNumAffected': 0, 'seriousNumAtRisk': 188, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Detection Rates for Adenomas and for Total Polyps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A - SC Followed by TEC', 'description': 'Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)\n\nThird Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon'}, {'id': 'OG001', 'title': 'Group B - TEC Followed by SC', 'description': 'Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)\n\nThird Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon'}], 'classes': [{'title': 'Polyps detected in first procedure', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}]}, {'title': 'Polyps detected in second procedure', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Adenomas detected in first procedure', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Adenomas detected in second procedure', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.', 'description': 'Numbers of polyps and adenomas detected in first and second procedures for each group', 'unitOfMeasure': 'Polyps or adenomas detected', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Times for Withdrawal Phase and for Complete Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All SC Procedures', 'description': 'For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during standard colonoscopies (SC)'}, {'id': 'OG001', 'title': 'All TEC Procedures', 'description': 'For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during Third Eye colonoscopies (TEC)'}], 'classes': [{'title': 'Mean withdrawal time', 'categories': [{'measurements': [{'value': '7.58', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '9.52', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'Mean total procedure time', 'categories': [{'measurements': [{'value': '16.97', 'spread': '9.90', 'groupId': 'OG000'}, {'value': '20.87', 'spread': '10.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.', 'description': 'For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in study (i.e., Group A and Group B combined)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A - SC Followed by TEC', 'description': 'Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)\n\nThird Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon'}, {'id': 'FG001', 'title': 'Group B - TEC Followed by SC', 'description': 'Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)\n\nThird Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '226'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Inadequate bowel preparation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Inability to reach cecum', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Technical error or malfunction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A - SC Followed by TEC', 'description': 'Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)\n\nThird Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon'}, {'id': 'BG001', 'title': 'Group B - TEC Followed by SC', 'description': 'Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)\n\nThird Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '57.8', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants in ITT population'}, {'title': 'Indication for colonoscopy procedure', 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}, {'title': 'Surveillance', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Diagnostic', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants in ITT population'}], 'populationDescription': 'Intention-to-treat population, i.e., those who were actually examined during the study'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 448}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2010-01-06', 'resultsFirstSubmitDate': '2015-08-28', 'studyFirstSubmitQcDate': '2010-01-06', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-28', 'studyFirstPostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection Rates for Adenomas and for Total Polyps', 'timeFrame': 'Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.', 'description': 'Numbers of polyps and adenomas detected in first and second procedures for each group'}], 'secondaryOutcomes': [{'measure': 'Times for Withdrawal Phase and for Complete Procedure', 'timeFrame': 'Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.', 'description': 'For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal', 'Neoplasms', 'Adenomas', 'Polyps', 'Miss rates', 'Detection rates', 'Colonoscope', 'Third Eye Retroscope'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '21067735', 'type': 'RESULT', 'citation': 'Leufkens AM, DeMarco DC, Rastogi A, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, Siersema PD; Third Eye Retroscope Randomized Clinical Evaluation [TERRACE] Study Group. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc. 2011 Mar;73(3):480-9. doi: 10.1016/j.gie.2010.09.004. Epub 2010 Nov 10.'}, {'pmid': '22807609', 'type': 'RESULT', 'citation': 'Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.'}]}, 'descriptionModule': {'briefSummary': 'The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone.\n\nPatients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first.\n\nResults from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.', 'detailedDescription': 'Colonoscopy is generally agreed to be the best method for detecting and removing pre-cancerous polyps, but some lesions can be missed, especially if they are located behind folds in the lining of the colon or behind flexures (sharp bends) in the colon.\n\nThe Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon. Previous studies have shown the device to be effective for detecting additional polyps that could not have been seen with the colonoscope alone.\n\nThe purpose of this research is to compare the additional diagnostic yield obtained by using the Third Eye® Retroscope® vs. the diagnostic yield for the standard colonoscope alone in the context of a randomized, controlled study design.\n\nPatients who are scheduled for colonoscopy will be recruited to the study and randomized to one of two groups. Each patient will undergo two "back-to-back" procedures.\n\nPatients in Group A (study group) will undergo a standard colonoscopy followed immediately by a Third Eye colonoscopy.\n\nPatients in Group B (control group) will undergo a Third Eye colonoscopy followed immediately by a standard colonoscopy.\n\nResults from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;\n* The patient must understand and provide written consent for the procedure.\n\nExclusion Criteria:\n\n* Patients with a history of colonic resection;\n* Patients with inflammatory bowel disease;\n* Patients with a personal history of polyposis syndrome;\n* Patients with suspected chronic stricture potentially precluding complete colonoscopy;\n* Patients with diverticulitis or toxic megacolon;\n* Patients with a history of radiation therapy to abdomen or pelvis;\n* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study."}, 'identificationModule': {'nctId': 'NCT01044732', 'acronym': 'TERRACE', 'briefTitle': 'Third Eye Retroscope Randomized Clinical Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avantis Medical Systems'}, 'officialTitle': 'Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)', 'orgStudyIdInfo': {'id': 'Avantis TER-08-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A - COLO, then TER', 'description': 'Complete examination with standard colonoscope ("COLO") followed by complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope', 'interventionNames': ['Device: Third Eye Retroscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B - TER, then COLO', 'description': 'Complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope, followed by complete examination with standard colonoscope ("COLO") alone', 'interventionNames': ['Device: Third Eye Retroscope']}], 'interventions': [{'name': 'Third Eye Retroscope', 'type': 'DEVICE', 'description': 'Device used with colonoscope to provide second, retrograde view of the colon', 'armGroupLabels': ['Group A - COLO, then TER', 'Group B - TER, then COLO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Veterans Administration Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Bayside Endoscopy Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'B-1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '20089 Rozzano', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': 'HA1 3UJ', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mark's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Peter D. Siersema, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregated, de-identified data to be published in peer-reviewed medical journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avantis Medical Systems', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}