A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope
Stopped early
Conditions studied: Digestive System Diseases
In brief
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.
Key facts
- Study ID
- NCT01262937
- Run by
- Yale University
- People needed
- 106
- Starts
- 2009-07-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2018-02-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia
- Patients undergoing ERCP for known or suspected biliary strictures.
You may not qualify if…
- have a known allergy or have had a prior adverse reaction to fluorescent contrast agents or chromoendoscopy stains
- are younger than age 18 or who are mentally or legally incapacitated or unable to give informed consent
- are pregnant or breastfeeding
- patients with advanced esophageal cancer
- acute gastrointestinal bleeding
- coagulopathy
- impaired renal function
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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