Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus
The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
• Subjects who are greater than 30 and less than 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 (RFA and/or Cryotherapy).
• Failed at least 1 ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-procedure dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
• Residual Barrett's length is ≥1 cm and ≤6 cm.
• No confirmed evidence of esophageal adenocarcinoma (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
• Patients who were on acid suppression therapy (i.e. PPIs) during the course of failed primary ablative therapy, and who can continue acid suppression therapy for the entire time they are on the clinical study.
• 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, as indicated.