Pilot Feasibility Study: Laser Marking Using the NvisionVLE® Imaging System

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 17

Inclusion Criteria

Inclusion criteria
* Patients over the age of 18
* Patients undergoing an upper endoscopy for Barrett surveillance with prior confirmed BE, with or without neoplasia.
* Ability to provide written, informed consent.
* Women of childbearing potential must be willing to take a pregnancy test.;Exclusion criteria
* Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe.
* Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe.
* Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe.
* Patients who are pregnant.
* Patients with a history of hemostasis disorders*.
* 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.

Exclusion Criteria

Exclusion criteria
* Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe.
* Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe.
* Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe.
* Patients who are pregnant.
* Patients with a history of hemostasis disorders*.
* 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures<br /><br>* Percentage of laser marks visible to the physician using WLE (white light<br /><br>endoscopy) and VLE<br /><br>* Positional accuracy of laser marks </p><br>

Secondary Outcome Measures