Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT01417702
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2011-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopy for Assessment of Mucosal Healing in IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2011-08-10', 'studyFirstSubmitQcDate': '2011-08-15', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal healing', 'timeFrame': 'up to three years', 'description': 'We will determine high-definition white light endoscopic and i-Scan features of mucosal inflammation (e.g. erosions, erythema, ulcerous lesions) in IBD in order to establish a new endoscopic classification of mucosal healing.'}], 'secondaryOutcomes': [{'measure': 'Histologic correlation', 'timeFrame': 'up to three years', 'description': 'Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse.'}, {'measure': 'Therapeutic effect', 'timeFrame': 'up to three years', 'description': 'We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics (e.g. erosions, ulcers, erythema) of mucosal healing.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['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. i-Scan use an endoscopic image from the video processor and reconstruct virtual images in real time, resulting in an improved contrast of the capillary patterns and enhancement of the mucosal surface (so called virtual chromoendoscopy).\n\nThe main objective of this study is to determine endoscopic features of mucosal healing in patients with IBD and to compare these features to clinical and histological data in order to establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing as a parameter of remission and relapse."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Crohn´s disease and ulcerative colitis were prospectively 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* Proctocolectomy'}, 'identificationModule': {'nctId': 'NCT01417702', 'briefTitle': 'Endoscopy for Assessment of Mucosal Healing in IBD', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Advanced Endoscopic Imaging Using HD+ Endoscopy and i-Scan for Assessment of Mucosal Healing in IBD', 'orgStudyIdInfo': {'id': 'HN-0007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Crohn´s disease - active', 'description': 'Patients in the active phase of the disease', 'interventionNames': ['Device: High-definition white light endoscopy and i-Scan']}, {'label': 'Crohn´s disease - quiescent', 'description': 'Patients in the quiescent phase of the disease', 'interventionNames': ['Device: High-definition white light endoscopy and i-Scan']}, {'label': 'Ulcerative colitis - active', 'description': 'Patients in the active phase of the disease', 'interventionNames': ['Device: High-definition white light endoscopy and i-Scan']}, {'label': 'Ucerative colitis - quiescent', 'description': 'Patients in the quiescent phase of the disease', 'interventionNames': ['Device: High-definition white light endoscopy and i-Scan']}], 'interventions': [{'name': 'High-definition white light endoscopy and i-Scan', 'type': 'DEVICE', 'description': 'Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.', 'armGroupLabels': ['Crohn´s disease - active', 'Crohn´s disease - quiescent', 'Ucerative colitis - quiescent', 'Ulcerative colitis - active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University of Erlangen-Nuremberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Helmut Neumann, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine I, University of Erlangen-Nuremberg, Germany'}, {'name': 'Markus F. Neurath, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine I, University of Erlangen-Nuremberg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}