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.
Subject has a BMI ≤ 50 kg/m2.
Subject has an ASA score of ≤ 3.
Subject has benign lesion(s) of the rectum or sigmoid colon, such as adenoma (with low- or high-grade dysplasia), neuroendocrine tumor, or other type of polyp as assessed by the most recent colonoscopy/flexible sigmoidoscopy.
Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
Subject has active left-sided inflammatory bowel disease.
Subject has an untreated active infection at the time of the procedure.
Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).
Single group
Endoscopic submucosal dissection using the ELS System
DeviceAll subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.
En Bloc Resection Rate
The percentage of target lesions across all subjects that are excised in a single specimen.
ESD-Related Complication-Free Rate
The percentage of subjects free from study device-related bleeding and perforation complications intraoperatively and postoperatively through Day 30.
R0 Resection Rate
The percentage of target lesions across all subjects that are resected with lateral and deep margins free of residual disease under microscopic visualization.
Conversion-Free Rate
The percentage of intended resections that do not require conversion to achieve successful completion of the resection.
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