ELS System for Colon Polyps
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but if you are on blood thinners like coumadin or heparin, you must be able to stop them before surgery.
What data supports the effectiveness of the ELS System treatment for colon polyps?
Research shows that endoscopic submucosal dissection (ESD) is effective in removing large colonic polyps in one piece, which can prevent the need for more invasive surgery. Studies have demonstrated high success rates in complete removal of these polyps, indicating the treatment's effectiveness.12345
Is the ELS System for Colon Polyps safe for humans?
How is the ELS System treatment for colon polyps different from other treatments?
The ELS System for colon polyps is unique because it uses an overtube system that creates a 'therapeutic zone' and allows for active retraction, which makes the procedure easier and reduces the risk of deep bowel wall injuries compared to traditional endoscopic submucosal dissection (ESD). This system also requires less lifting solution, making the process more efficient.27101112
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for adults aged 22-80 with a BMI ≤ 50 kg/m2 and an ASA score of ≤ 3, who have benign lesions in the rectum or sigmoid colon. Lesions must be ≤7 cm in size and cover no more than 75% of the colorectal circumference. Participants must consent to undergo endoscopic submucosal dissection.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo endoscopic submucosal dissection (ESD) with the ELS System for benign lesions in the rectum and sigmoid colon
Postoperative Follow-up
Safety and effectiveness outcomes are assessed at discharge, Day 7, and Day 30
Long-term Follow-up
Subjects in Arm 2 undergo 5-year follow-up to assess long-term oncological outcomes
Treatment Details
Interventions
- Endoscopic submucosal dissection using the ELS System
Find a Clinic Near You
Who Is Running the Clinical Trial?
EndoQuest Robotics, Inc.
Lead Sponsor