Status:
COMPLETED
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
Lead Sponsor:
Mauna Kea Technologies
Collaborating Sponsors:
Cellvizio Inc.
Emissary International LLC
Conditions:
Barrett Syndrome
Barrett's Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging de...
Eligibility Criteria
Inclusion
- Patients with documented or suspected Barrett's esophagus presenting for endoscopy
- Age \> 18 years
- Ability to provide written, informed consent
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00795184
Start Date
November 1 2008
End Date
February 1 2010
Last Update
May 3 2016
Active Locations (5)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224
2
Veterans Affairs Hospital
Kansas City, Missouri, United States, 64128
3
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
4
Centre Hospitalier Universitaire
Nantes, France, 44093 Cedex 1