Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-30 @ 7:43 PM
Study NCT ID:
NCT01384695
Status:
TERMINATED
Last Update Posted:
2016-01-12
First Post:
2011-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019793', 'term': 'Fluorescein'}, {'id': 'D011370', 'term': 'Proflavine'}], 'ancestors': [{'id': 'D005452', 'term': 'Fluoresceins'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014966', 'term': 'Xanthenes'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000609', 'term': 'Aminoacridines'}, {'id': 'D000166', 'term': 'Acridines'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'whyStopped': 'Low/no enrollment. No subjects were enrolled over the past year.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-08', 'studyFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2011-06-28', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine whether tissue is neoplastic or non-neoplastic', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Barrett's esophagus", 'confocal microendoscopy'], 'conditions': ['GERD', "Barrett's Esophagus"]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient 18 years or older\n* colonoscopy for screening or surveillance of polyps or disease of colon\n* anoscopy because of suspected or known anal dysplasia or neoplasia\n\nExclusion Criteria:\n\n* patient unable to provide informed consent\n* patient found unfit for standard colonoscopy or anoscopy with biopsies'}, 'identificationModule': {'nctId': 'NCT01384695', 'briefTitle': 'A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1', 'organization': {'class': 'INDIV', 'fullName': 'Anandasabapathy, Sharmila, M.D.'}, 'officialTitle': 'A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1', 'orgStudyIdInfo': {'id': 'GCO# 09-0696 Project 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluorescein', 'description': 'Confocal imaging using contrast agent fluorescein', 'interventionNames': ['Drug: Proflavine hemisulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Proflavine hemisulfate', 'description': 'confocal imaging using contrast agent proflavine', 'interventionNames': ['Drug: Fluorescein']}], 'interventions': [{'name': 'Fluorescein', 'type': 'DRUG', 'description': 'fluorescent contrast agent, Fluorescein 5ml', 'armGroupLabels': ['Proflavine hemisulfate']}, {'name': 'Proflavine hemisulfate', 'type': 'DRUG', 'otherNames': ['Proflavine'], 'description': '3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)', 'armGroupLabels': ['Fluorescein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sharmila Anandasabapathy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mt. Sinai School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anandasabapathy, Sharmila, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}