A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
NCT ID: NCT01384695
Last Updated: 2016-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
67 participants
INTERVENTIONAL
2009-06-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Fluorescein
Confocal imaging using contrast agent fluorescein
Proflavine hemisulfate
3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
Proflavine hemisulfate
confocal imaging using contrast agent proflavine
Fluorescein
fluorescent contrast agent, Fluorescein 5ml
Interventions
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Fluorescein
fluorescent contrast agent, Fluorescein 5ml
Proflavine hemisulfate
3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* colonoscopy for screening or surveillance of polyps or disease of colon
* anoscopy because of suspected or known anal dysplasia or neoplasia
Exclusion Criteria
* patient found unfit for standard colonoscopy or anoscopy with biopsies
18 Years
ALL
No
Sponsors
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Anandasabapathy, Sharmila, M.D.
INDIV
Responsible Party
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Principal Investigators
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Sharmila Anandasabapathy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mt. Sinai School of Medicine
Locations
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Mount Sinai Medical Center
New York, New York, United States
Countries
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Other Identifiers
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GCO# 09-0696 Project 1
Identifier Type: -
Identifier Source: org_study_id
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