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.
Study Type
OBSERVATIONAL
Enrollment
10
Columbia University Medical Center
New York, New York, United States
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.
Time frame: Day of procedure
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?).
Time frame: Day of procedure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.