Clinical Trials

Inclusion Criteria: 

• Age of 18-85 years old (inclusive). 
• Dysplastic BE, confirmed by the central pathologist; specifically: 
  • Low grade dysplasia documented on biopsy within 6 months of consent date; or
  • High grade dysplasia documented on biopsy within 6 months of consent date.
• Barrett's extent of: C/M≥1 cm and C/M ≤ 6 cm using the Prague criteria [C = circumferential extent of disease / M = maximum extent of disease].
• Ability to provide written and informed consent.

Exclusion Criteria:

• Barrett's extent of: C/M <1 cm or a C/M-value > 6 cm using the Prague criteria. 
• Prior EMR (endoscopic mucosal resection) for G3/G4; L1; V1; R1 (vertical margin only) or submucosal invasion.
• Presence of endoscopically visible abnormalities at the time of initial study treatment with HAPC or RFA. These participants can undergo EMR and then continue in the trial after a suitable healing period, provided randomization can occur within 90 days of consent. 
• Presence of invasive cancer on biopsy.
• Known pregnancy or plans to become pregnant.
• Complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated pre-existing significant esophageal pain or dysphagia; - BE >80% has been resected by EMR.
• Incomplete wound healing 3 months post-EMR despite adequate PPImedication.
• Prior ablative therapy in the esophagus but prior EMR allowed.
• Active esophagitis or stricture precluding passage of scope.
• Presence of esophageal varices.
• Anticoagulant therapy (apart from aspirin or NSAIDS) that cannot be discontinued prior to therapy or uncorrectable hemostatic disorders.
• Life expectancy less than 2 years.
• Previous gastrectomy or other gastric surgery other than uncomplicated fundoplication.