Barretts Esophagus With Dysplasia Clinical Trial
Official title:
EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus.
Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an
indication for ablation treatment. These include patients with low grade dysplasia (LGD),
high grade dysplasia (HGD) or residual Barrett's after a complete endoscopic resection of a
lesion containing HGD or esophageal adenocarcinoma. Ablation treatment will be performed by
the EndoRotor ablation device, followed by surveillance endoscopy at 3 months where the
feasibility for ablation will be assessed. During the 3 months follow-up, all adverse events
such as perforation, post-procedural bleeding, stricture, and pain will be registered.
The EndoRotor® System is in automated mechanical endoscopic mucosal resection system for use
in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it,
automatically sending the tissue to a collection trap for histological evaluation.
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