Ensayos clínicos

Inclusion Criteria:

• Males and females over the age of 18 years.
• Patients with either suspected or confirmed Barrett's-associated high grade dysplasia (HGD) or intramucosal cancer (IMC) presenting for endoscopy possibly requiring EMR.
• Ability to provide written, informed consent.
• Females must be willing to take a pregnancy test if still capable of bearing a child.

Exclusion Criteria:

• Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)*.
• Patients with esophageal varices that preclude biopsies.
• Presence of an esophageal mass/cancer that precludes full distention of the balloon from the Nvision balloon guide sheath.
• Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision guide sheath.
• Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the Nvision balloon guide sheath.
• Patients with known eosinophilic esophagitis.
• Patients who are pregnant.
• Patients with a history of hemostasis disorders.*
  • Patients on anticoagulation undergoing low risk procedures are not excluded.

* 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 Willebrand's disease or other known platelet malfunction disorders.