A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1



Status:Terminated
Conditions:Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2009
End Date:February 2014

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A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1

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.


Inclusion Criteria:

- patient 18 years or older

- colonoscopy for screening or surveillance of polyps or disease of colon

- anoscopy because of suspected or known anal dysplasia or neoplasia

Exclusion Criteria:

- patient unable to provide informed consent

- patient found unfit for standard colonoscopy or anoscopy with biopsies
We found this trial at
1
site
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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mi
from
New York, NY
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