drugset / Trial / NCT01384695

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

NCT01384695

Phase 0 Terminated 67 enrolled Anandasabapathy, Sharmila, M.D.
RandomizedParallel-groupOpen-labelScreening

Summary

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.

Timeline

Start
2009-06
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluorescein Diagnostic / imaging agent 5 ml
Subject Proflavine Diagnostic / imaging agent 3 ml