drugset / Trial / NCT01384695
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluorescein | Diagnostic / imaging agent | 5 ml | — |
| Subject | Proflavine | Diagnostic / imaging agent | 3 ml | — |