PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
Subject is ≥22 years at the time of consent. [+6]
Subject anatomy is unsuitable for endoscopic visualization or endoluminal surger... [+18]