Barrett's esophagus early esophageal cancer
Conditions
Interventions
None listed
Sponsors
Ninepoint Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 (
Exclusion criteria
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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures * Percentage of laser marks visible to the physician using WLE (white light endoscopy) and VLE * Positional accuracy of laser marks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measures * All adverse events will be collected and analyzed. | — |
Countries
Netherlands
Outcome results
None listed