High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System

Study Overview
=================
Brief Summary
-----------------
This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE Optical Probe to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.

Conditions
-----------------
Undergoing Esophagogastroduodenoscopy (EGD)

Intervention / Treatment
-----------------
* Device: NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females over the age of 18 years. Patients presenting for an EGD. 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 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 NvisionVLE catheter. Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE catheter. Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the NvisionVLE catheter. Patients with known eosinophilic esophagitis. Patients that are pregnant. Patients with a history of hemostasis disorders**. Patients on anticoagulation undergoing low risk procedures are not excluded. ** Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willibrand's disease or other known platelet malfunction disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Undergoing EGD<br> | Device: NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit<br>* The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be the number of patients achieving a VLE (volumetric laser endomicroscopy) image that includes stomach, gastro esophageal junction (GEJ) and esophagus. | Achieving a VLE image is defined as completing a full 6cm scan. This will be presented as a percentage of patients. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console. | Procedural workflow and physician interface to the console will be assessed by a questionnaire that will be completed by the investigational staff involved in the procedure. | 1 day |