Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-30 @ 7:45 PM
Study NCT ID:
NCT00449995
Status:
COMPLETED
Last Update Posted:
2008-12-24
First Post:
2007-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confocal Laserscanning Microscopy for Detection of Barretts Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018613', 'term': 'Microscopy, Confocal'}], 'ancestors': [{'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-23', 'studyFirstSubmitDate': '2007-02-23', 'studyFirstSubmitQcDate': '2007-03-20', 'lastUpdatePostDateStruct': {'date': '2008-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus'}], 'secondaryOutcomes': [{'measure': 'inter- and intra observer variability for confocal laser scanning microscopy'}]}, 'conditionsModule': {'conditions': ['Barrett Esophagus']}, 'descriptionModule': {'briefSummary': 'Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 80 years\n* regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium C0M1)\n* patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes \\<1cm\n* patients presenting with suspected intraepithelial neoplastic changes\n* patients receiving acid suppressive therapy in standard dose for at least 4 weeks\n\nExclusion Criteria:\n\n* no informed consent\n* thrombocytopenia, quick \\<50%, PTT \\>50 sec\n* patients with coronary heart disease or existent valve plasties\n* women with potential pregnancy\n* patients with chronic renal failure\n* patients with allergies\n* patients with chronic obstructive pulmonary disease'}, 'identificationModule': {'nctId': 'NCT00449995', 'briefTitle': 'Confocal Laserscanning Microscopy for Detection of Barretts Esophagus', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.', 'orgStudyIdInfo': {'id': '1129/04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'confocal laser microscopy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': '2nd department of the Medical Clinic of the Technical University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Alexander Meining, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Technische Universität Dresden', 'class': 'OTHER'}]}}}