NCT01262937

A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

A Pilot Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the project is to determine whether confocal endomicroscopy can be used to identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared with histologic specimens as a reference. The project will evaluate those at risk for or with known Barrett's esophagus, and those with known or suspected biliary strictures. It is our hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.

Detailed description

This study was amended from it's initial design to increase the number of patients to 200. The study was terminated in July 2016 after 106 patients were enrolled and had completed the study.

Conditions

• Digestive System Diseases

Interventions

Type	Name	Description
DEVICE	Confocal Imaging	Confocal imaging performed of the digestive system with the use of confocal miniprobes such as the Gastroflex UHD and Cholangioflex miniprobes (Cellvizio, Mauna Kea, Paris, France)

Timeline

• Start date: 2009-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2010-12-20
• Last updated: 2018-02-26

Locations

1 site across 1 country: United States