PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

Overview

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.

This study will be a prospective, single treatment, multi-center, open-label clinical study. The objective of this study is to evaluate the safety and effectiveness of the ELS System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. 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 (up to 7 cm in size and up to 75% of the colorectal circumference). The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge, Day 7 (-2 +7 days) and Day 30 (-7 +14 days). Subjects with lesions resected using the study device will be allocated into two different study arms: Arm 1: * Subjects with benign final pathology and R0 resection is achieved; or, * Subjects with benign (but not pre-cancerous) final pathology without R0 resection. Arm 2: * Subjects with final pathology that is upstaged to cancer; or, * Subjects with benign (and pre-cancerous) final pathology without R0 resection. Subjects in Arm 1 will complete the study after Day 30. Arm 1 subjects in which R0 resection was not achieved should receive routine care, including any additional treatment as needed at the discretion of the physician, even if occurring after study exit at Day 30. Any non-study-related care of Arm 1 subjects occurring after study exit may be performed by the Investigator or transferred to another physician at the discretion of the Investigator and will not be collected for this trial. Subjects in Arm 2 will undergo 5-year follow-up to assess long-term oncological outcomes including local recurrence, disease-free survival and overall survival. To ensure a total of 50 subjects are included in the final analysis, the study may enroll up to 56 subjects at up to 6 clinical sites in the U.S. No individual site will be permitted to enroll more than 60% of the subjects in the final data set to ensure that a single site does not dominate the results and analysis. Enrollment will end when 50 subjects have completed 30-day follow-up or the maximum enrollment number has been reached, whichever occurs first. In addition to the total number of enrolled subjects, each Investigator will enroll up to 2 lead-in cases. Lead-in cases will be analyzed separately in the final clinical study report.