Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT00659867
Status:
TERMINATED
Last Update Posted:
2016-09-27
First Post:
2008-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endomicroscopy in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'whyStopped': 'Recruitment problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2008-04-14', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN', 'timeFrame': 'Day 1 (colonoscopy)'}], 'secondaryOutcomes': [{'measure': 'Efficacy of chromoscopy-guided endomicroscopy in the detection of lesions and in the reduction of the number of biopsies. Time needed for the examination will be measured and compared between the two groups.', 'timeFrame': 'Day 1 (colonoscopy)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Endomicroscopy', 'Chromoendoscopy', 'Confocal colonoscope', 'Surveillance colonoscopy'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '18192453', 'type': 'BACKGROUND', 'citation': 'Hurlstone DP, Kiesslich R, Thomson M, Atkinson R, Cross SS. Confocal chromoscopic endomicroscopy is superior to chromoscopy alone for the detection and characterisation of intraepithelial neoplasia in chronic ulcerative colitis. Gut. 2008 Feb;57(2):196-204. doi: 10.1136/gut.2007.131359.', 'retractions': [{'pmid': '18949845', 'source': 'Gut. 2008 Nov;57(11):1634'}]}]}, 'descriptionModule': {'briefSummary': 'This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be available before any trial-related procedures\n* Male and female patients aged 18 years and older\n* Clinically and histologically verified UC\n* Duration or Colitis ulcerosa \\>8 years (date of first diagnosis)\n* Colitis Activity Index ≤ 8\n* Activity index of Truelove and Witts: mild\n* Ability of subject to understand character and individual consequences of clinical trial\n* For women with childbearing potential, adequate contraception.\n\nExclusion Criteria:\n\n* Known intraepithelial neoplasia or colorectal cancer\n* Coagulopathy (Prothrombin time \\<50% of control, Partial thromboplastin time \\>50 s)\n* Impaired renal function (Creatinine \\>1.2 mg/dL)\n* Pregnancy or breast feeding\n* Inability to obtain informed consent\n* Active GI Bleeding\n* Known allergy to methylene blue or fluorescein\n* Participation in other clinical trials within the last 4 weeks'}, 'identificationModule': {'nctId': 'NCT00659867', 'briefTitle': 'Endomicroscopy in Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'PENTAX Europe GmbH'}, 'officialTitle': 'Chromoscopy-guided Endomicroscopy With the PENTAX EC-3870CIFK / EC-3870CILK Confocal Colonoscopes for the Detection of Intraepithelial Neoplasias in Subjects With Long Standing Ulcerative Colitis', 'orgStudyIdInfo': {'id': '2006-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Chromoscopy-guided endomicroscopy with targeted biopsies', 'interventionNames': ['Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Standard endoscopy with random and targeted biopsies', 'interventionNames': ['Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes']}], 'interventions': [{'name': 'PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes', 'type': 'DEVICE', 'otherNames': ['Endomicroscope'], 'description': 'chromoscopy-guided endomicroscopy with targeted biopsies', 'armGroupLabels': ['A']}, {'name': 'PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes', 'type': 'DEVICE', 'otherNames': ['Endomicroscope'], 'description': 'Standard endoscopy with random and targeted biopsies', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Benjamin Franklin, Medizinische Klinik I', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '26013', 'city': 'Crema', 'country': 'Italy', 'facility': 'Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division', 'geoPoint': {'lat': 45.36264, 'lon': 9.68176}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'European Institute of Oncology, Division of Endoscopy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Ralf Kiesslich, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johannes Gutenberg-Universität Mainz, I. Med. Klinik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PENTAX Europe GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Trial Coordinator', 'investigatorFullName': 'Annette Weissmann', 'investigatorAffiliation': 'PENTAX Europe GmbH'}}}}