Barrett's esophagus, early adenocarcinoma
Conditions
Interventions
several laser marks will be placed at several locations in the esophagus and cardia in the stomach. Biopsies will be obtained of some of the marked areas.
Sponsors
AMC Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: • Patients over the age of 18 • Patients undergoing an upper endoscopy for BE 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
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • All adverse events will be collected and analyzed. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to determine the visibility and positional accuracy of laser marks applied by the NvisionVLE Imaging System. Primary outcome measures •Percentage of laser marks visible to the physician using WLE and VLE •Positional accuracy of laser marks | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
Academic Medical Center Bldg. C2-210, Meibergdreef
Outcome results
None listed