Viewing Study NCT00449995


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Study NCT ID: NCT00449995
Status: COMPLETED
Last Update Posted: 2008-12-24
First Post: 2007-02-23
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Confocal Laserscanning Microscopy for Detection of Barretts Esophagus
Sponsor: Technical University of Munich
Organization:

Study Overview

Official Title: Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.
Status: COMPLETED
Status Verified Date: 2008-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: