High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:January 2012
Contact:John C Maffeo, MSHS
Email:jmaffeo@ninepointmedical.com

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The primary objective of this clinical trial is to evaluate the performance of the Nvision
Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects
undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training
implications for introducing this new imaging modality.


Inclusion Criteria:

- Males and females over the age of 18 years.

- Patients with either suspected BE presenting for endoscopy or patients with
documented BE presenting for follow-up endoscopy likely to require a biopsy or
patients presenting for endoscopy for non-BE related conditions other than esophageal
varices.

- Ability to provide written, informed consent.

- Females who are able to become pregnant, are willing to take a pregnancy test.

Exclusion Criteria:

- Patients on anticoagulation undergoing high risk procedures in accordance to American
Society For Gastrointestinal Endoscopy (ASGE) guideline for the management of
antithrombotic agents for endoscopic procedures (2009).

- Patients with esophageal varices that preclude biopsies.

- Presence of an esophageal mass that precludes full distention of the balloon from the
Nvision balloon guide sheath.

- Patients with esophageal strictures that would prevent adequate expansion of the
balloon from the Nvision balloon guide sheath.

- Patients with known inflammatory disease, esophageal tears or ulcers, which would
prohibit full distention of the balloon from the Nvision balloon guide sheath.

- Patients with known eosinophilic esophagitis.

- Patients that are pregnant.

- Patients with a history of hemostasis disorders.
We found this trial at
3
sites
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
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