Colorectal Lesions Clinical Trial
Official title:
PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest ELS System
The objective of this study is to evaluate the safety and effectiveness of the EndoQuest Robotics Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo partial thickness resection 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 and Days 7 and 30.
This study will be a prospective, single-arm, 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 partial thickness resection, 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). Any subjects with lesions upstaged to cancer (must be histologically confirmed) post resection using the ELS System will be followed under a separate protocol for 5 years in accordance with NCCN guidelines and evaluated for local recurrence, disease-free survival and overall survival. Clinical data in the final clinical study report will include study results through Day 30. This study will enroll a total of 40 subjects at up to 5 clinical sites in the U.S. No individual site will be permitted to enroll more than 60% (24) of the subjects for the entire IDE study to ensure that a single site does not dominate the results and analysis. In addition to the total of 40 enrolled subjects, each Investigator will enroll 2 lead-in cases. Lead-in cases will be analyzed separately in the final clinical study report. ;
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