Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01524120
Status:
WITHDRAWN
Last Update Posted:
2020-12-14
First Post:
2012-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biopsies were taken from every patient for subsequent histological analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2012-01-29', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal healing', 'timeFrame': '3 years', 'description': 'We will determine endoscopic (e.g. ulcera, erythema) and endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to define new criteria of mucosal healing and to define factors of disease remission and relapse.'}], 'secondaryOutcomes': [{'measure': 'Histologic correlation', 'timeFrame': '3 years', 'description': 'Comparison of clinical and histopathological data with endoscopic and endomicroscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.'}, {'measure': 'Therapeutic effect', 'timeFrame': '3 years', 'description': 'We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment, corticosteroids) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage) and remission and relapse rate.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mucosal healing'], 'conditions': ['Inflammatory Bowel Disease', "Crohn's Disease", 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn\'s disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.\n\nThe main objective of this study is to determine endoscopic and endomicroscopic features of mucosal healing in patients with IBD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Crohn´s disease and ulcerative colitis. Only patients with mucosal healing are included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age 18-85 years\n* Ability of subjects to understand character and individual consequences of clinical trial\n* Subjects undergoing colonoscopy\n\nExclusion Criteria:\n\n* Inability to provide written informed consent\n* Severe Coagulopathy (Prothrombin time \\< 50% of control, Partial thromboplastin time \\> 50 s)\n* Pregnancy or breast feeding\n* Active gastrointestinal bleeding\n* Residing in institutions (e.g. prison)\n* Known allergy against fluorescein'}, 'identificationModule': {'nctId': 'NCT01524120', 'briefTitle': 'Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'orgStudyIdInfo': {'id': 'HN-0009'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Crohn's disease (CD)", 'description': 'Patients with CD and mucosal healing on endoscopy.', 'interventionNames': ['Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)']}, {'label': "Crohn's disease", 'description': 'Patients with CD and mucosal healing on endomicroscopy.', 'interventionNames': ['Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)']}, {'label': 'Ulcerative colitis (UC)', 'description': 'Patients with UC and mucosal healing on endoscopy.', 'interventionNames': ['Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)']}, {'label': 'Ulcerative colitis', 'description': 'Patients with UC and mucosal healing on endomicroscopy.', 'interventionNames': ['Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)']}], 'interventions': [{'name': 'Endoscopy (EPK-i, Pentax, Tokyo, Japan)', 'type': 'DEVICE', 'description': 'Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.', 'armGroupLabels': ["Crohn's disease (CD)"]}, {'name': 'Endomicroscopy (iCLE, Pentax, Tokyo, Japan)', 'type': 'DEVICE', 'description': 'Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.', 'armGroupLabels': ["Crohn's disease"]}, {'name': 'Endoscopy (EPK-i, Pentax, Tokyo, Japan)', 'type': 'DEVICE', 'description': 'Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.', 'armGroupLabels': ['Ulcerative colitis (UC)']}, {'name': 'Endomicroscopy (iCLE, Pentax, Tokyo, Japan)', 'type': 'DEVICE', 'description': 'Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.', 'armGroupLabels': ['Ulcerative colitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University of Erlangen-Nuremberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Markus F. Neurath, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erlangen-Nürnberg'}, {'name': 'Helmut Neumann, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erlangen-Nürnberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}