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

Stopped early · Early Phase 1

Conditions studied: GERD, Barrett's Esophagus

In brief

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.

Key facts

Study ID

NCT01384695

Run by

Anandasabapathy, Sharmila, M.D.

People needed

67

Starts

2009-06-01

Expected to finish

2014-02-01

Last updated by the study team

2016-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• patient unable to provide informed consent
• patient found unfit for standard colonoscopy or anoscopy with biopsies

Where it is running

• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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