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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 catheter to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.
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| 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. | Day of procedure |
| 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 (eg - Were you (physician) able to position the catheter in the desired position?). | Day of procedure. |
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Inclusion Criteria:
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 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 would 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**.
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Males and females >18 years of age undergoing esophagogastroduodenoscopy (EGD).
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| Name | Affiliation | Role |
|---|---|---|
| John Poneros, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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