Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

Completed · Not applicable

Conditions studied: Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus, Adenocarcinoma

In brief

This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

Key facts

Study ID

NCT00795184

Run by

Mauna Kea Technologies

People needed

122

Starts

2008-11-01

Expected to finish

2010-02-01

Last updated by the study team

2016-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with documented or suspected Barrett's esophagus presenting for endoscopy
• Age > 18 years
• Ability to provide written, informed consent

You may not qualify if…

• Presence of erosive esophagitis
• Inability to obtain biopsies due to anticoagulation, varices, etc.
• Allergy to fluorescein, pregnancy
• Presence of an esophageal mass other than small 10mm or less nodules
• Renal insufficiency

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States
• Veterans Affairs Hospital — Kansas City, Missouri, United States
• New York Presbyterian Hospital/Columbia University Medical Center — New York, New York, United States
• Centre Hospitalier Universitaire — Nantes, France
• Klinikum rechts der Isar — Munich, Bavaria, Germany

Full record on ClinicalTrials.gov

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