Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-03-03 @ 9:16 PM
Study NCT ID:
NCT03814369
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2019-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AmplifEYE Colonoscopy vs Standard Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-24', 'studyFirstSubmitDate': '2019-01-20', 'studyFirstSubmitQcDate': '2019-01-20', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': '1 day', 'description': 'number of patients in whom at least one adenoma could be found'}], 'secondaryOutcomes': [{'measure': 'Polyp detection rate', 'timeFrame': '1 day', 'description': 'number of patients in whom at least one polyp could be found'}, {'measure': 'Serrated polyp detection rate', 'timeFrame': '1 day', 'description': 'number of patients in whom at least one serrated polyp could be found'}, {'measure': 'caecal intubation rate', 'timeFrame': '1 day', 'description': 'number of patients in whom caecal intubation is acheived'}, {'measure': 'caecal intubation time', 'timeFrame': '1 day', 'description': 'time beginning with the insertion of the colonoscope until reaching the caecum'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['colonoscopy', 'adenoma detection rate', 'colorectal cancer screening', 'new technology'], 'conditions': ['Colon Polyp', 'Adenoma Colon', 'Serrated Polyp', 'Colonic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24047059', 'type': 'BACKGROUND', 'citation': 'Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.'}, {'pmid': '8978338', 'type': 'BACKGROUND', 'citation': 'Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.'}, {'pmid': '24693890', 'type': 'BACKGROUND', 'citation': 'Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.'}, {'pmid': '20463339', 'type': 'BACKGROUND', 'citation': 'Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.'}, {'pmid': '25470133', 'type': 'BACKGROUND', 'citation': 'Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.'}, {'pmid': '26171436', 'type': 'BACKGROUND', 'citation': 'Sawatzki M, Meyenberger C, Marbet UA, Haarer J, Frei R. Prospective Swiss pilot study of Endocuff-assisted colonoscopy in a screening population. Endosc Int Open. 2015 Jun;3(3):E236-9. doi: 10.1055/s-0034-1391418. Epub 2015 Feb 27.'}, {'pmid': '26674360', 'type': 'BACKGROUND', 'citation': 'van Doorn SC, van der Vlugt M, Depla A, Wientjes CA, Mallant-Hent RC, Siersema PD, Tytgat K, Tuynman H, Kuiken SD, Houben G, Stokkers P, Moons L, Bossuyt P, Fockens P, Mundt MW, Dekker E. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut. 2017 Mar;66(3):438-445. doi: 10.1136/gutjnl-2015-310097. Epub 2015 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical data on this relatively new device is lacking and this study aims to compare the adenoma and polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.', 'detailedDescription': 'This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All study team members will have a prior run-in phase of performing at least 5 AmplifEYE colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time, colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 50 to 79 years old\n* Scheduled for screening, surveillance or diagnostic colonoscopy\n\nExclusion Criteria:\n\n* Colonic strictures\n* History of bowel surgery\n* Per-rectal bleeding within six weeks\n* Inflammatory bowel disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03814369', 'briefTitle': 'AmplifEYE Colonoscopy vs Standard Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Queen Elizabeth Hospital, Hong Kong'}, 'officialTitle': 'Use of AmplifEYE-assisted Colonoscopy Compared to Standard Colonoscopy in Polyp and Adenoma Detection', 'orgStudyIdInfo': {'id': 'amplifeye'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AmplifEYE colonoscopy', 'description': 'Colonoscopy performed with AmplifEYE equipped', 'interventionNames': ['Device: AmplifEYE']}, {'type': 'NO_INTERVENTION', 'label': 'Standard colonoscopy', 'description': 'Standard colonoscopy performed'}], 'interventions': [{'name': 'AmplifEYE', 'type': 'DEVICE', 'description': 'AmplifEYE colonoscopy', 'armGroupLabels': ['AmplifEYE colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Medicine, Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Shun Fung Sze, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Queen Elizabeth Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Elizabeth Hospital, Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Our Lady of Maryknoll Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Consultant', 'investigatorFullName': 'Sze Shun Fung', 'investigatorAffiliation': 'Queen Elizabeth Hospital, Hong Kong'}}}}