Clinical Trials

Inclusion Criteria:

• Subjects who are  ≥ 30 and ≤ 90 years of age, inclusive of males and females.
• Subjects with confirmed Barrett's Esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria:
  • Failed 3 ablative procedures (Cryotherapy, APC or RFA);
  • Failed 2 ablative procedures (Cryotherapy, APC, or RFA) with less than 50% reduction of Barrett's Esophagus after second procedure;
  • Failed at least 1 ablative procedure (Cryotherapy, APC, or RFA) and are intolerant to the prior procedure due to pain.
  • Or histologic persistence of intestinal metaplasia (any non-squamous epithelial lesion) following treatment and failed eradication.
• Residual Barrett's length is ≥ 1 cm and ≤ 6 cm.
• No confirmed evidence of EAC at the time of therapy.
• Subject capable of giving informed consent.
• Subject has a reasonable expectation for prolonged survival (greater than 2 years).
• Subject can tolerate repeated endoscopic procedures.
• Absence of strictures refractory to dilation that preclude the passage of the endoscope.
• Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 12 months.

Exclusion Criteria:

• Subject unable to give informed consent.
• Subject is unwilling to return for repeated endoscopies.
• Confirmed endoscopic and / or histologic evidence of EAC at time of therapy.
• Residual Barrett’s longer than 6 cm.
• Subjects with nodular Barrett’s Esophagus.
• Subjects who are on anticoagulant therapy that cannot be discontinued for 5 days before and after the procedure.
• Subjects with known coagulopathy defined as abnormal prothrombin or partial thromboplastin time.
• History of esophageal varices.
• LA Grade B or C esophagitis.
• Esophageal stricture refractory to dilation preventing passage of endoscope or catheter.
• Any previous esophageal surgery, except fundoplication without complications.
• Medically uncorrectable hypotension or hypertension.
• Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
• Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
• Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions.
• Patient has a known significant concomitant illness with a life expectancy of < 2 years.
• Subject is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.