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.
Prospective, multi-center, randomized controlled trial, pivotal, investigational device exemption (IDE) to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ablative therapy in subjects with refractory Barrett's Esophagus. The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
Continued ablation control shall include either cryotherapy or continued radial frequency ablation.
The Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGUniversity of Rochester Medical Center
Rochester, New York, United States
RECRUITINGSahlgrenska University Hospital
Gothenburg, Sweden
Incidence of complete removal of refractory Barrett's esophagus
The primary effectiveness endpoint for this study is the complete removal of refractory Barrett's esophagus in no more than three treatments as assessed by a biopsy negative for Barrett's esophagus at the 12 month follow-up visit.
Time frame: 12 months
Rate of device- and procedure-related serious adverse events (SAEs)
The primary safety endpoint for this study is the rate of device- and procedure-related serious adverse events (SAEs) for bleeding, perforation, and stricture in the EndoRotor arm will be no greater than that of the continued ablative therapy arm.
Time frame: 12 months
Activated Fibroblasts
Percent reduction of activated fibroblasts in the area with Barrett's esophagus that was resected using EndoRotor at initial treatment session through the 12 month follow-up visit as per the histological findings of keyhole technique biopsies. - this point is only assessed in the first 5 EndoRotor subjects
Time frame: 12 months
Percent Reduction of Barrett's Esophagus
Percent reduction of Barrett's esophagus that was resected or ablated during the initial treatment session through the 12 month follow-up visit as calculated using the Prague classification measurements of estimated circumference and maximal length.
Time frame: 12 months
Post Procedure Pain
Assessment of subject post procedure pain as compared to the control arm by means of a visual analogue pain scale. The visual analogue pain scale used for this study allows a patient to record their pain using a scoring system from 0 to 10. Zero representing no pain, 5 representing moderate pain, and 10 representing the worst possible pain. Lower scores represent a better score.
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NHS University College Hospital
London, United Kingdom
RECRUITINGNottingham University Hospitals NHS Trust and University of Nottingham
Nottingham, United Kingdom
RECRUITINGTime frame: 9 months