NCT01384695

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

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Anandasabapathy, Sharmila, M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• GERD
• Barrett's Esophagus

Interventions

Type	Name	Description
DRUG	Fluorescein	fluorescent contrast agent, Fluorescein 5ml
DRUG	Proflavine hemisulfate	3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)

Timeline

• Start date: 2009-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-06-29
• Last updated: 2016-01-12

Locations

1 site across 1 country: United States