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

NACompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

September 30, 2009

Study Completion Date

February 28, 2010

Conditions
Barrett SyndromeBarrett's SyndromeBarrett's EsophagusBarrett EsophagusAdenocarcinoma
Interventions
DEVICE

Imaging procedures (NBI)

"Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order.~Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete.~Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed.~After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites."

DEVICE

HDWLE

DEVICE

pCLE

Trial Locations (5)

10032

New York Presbyterian Hospital/Columbia University Medical Center, New York

32224

Mayo Clinic, Jacksonville

64128

Veterans Affairs Hospital, Kansas City

44093 Cedex 1

Centre Hospitalier Universitaire, Nantes

Unknown

Klinikum rechts der Isar, Munich

Sponsors
All Listed Sponsors
collaborator

Cellvizio Inc.

INDUSTRY

collaborator

Emissary International LLC

INDUSTRY

lead

Mauna Kea Technologies

INDUSTRY