The goal of this clinical trial is to compare the safety and effectiveness of the GripTract GI Endoscopic Tissue Manipulator to the current standard of care for complex polypectomies in adults. The main questions it aims to answer are:
1. How does the number and severity of Device-Attributable Adverse Events compare to the current standard of care? 2. How is the procedure time affected? 3. Is the ability to resect the tissue en bloc affected? 4. What is the user feedback on the device performance?
Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
Patients capable of giving informed consent English and lacking cognitive impairment
No medical contraindication to endoscopic mucosal resection or endoscopic submucosal dissection
Patients less than 21 years of age
Any contraindication to colonoscopy with due to subject's colon anatomy (i.e., structure)
History of open or laparoscopic colorectal surgery
History of Inflammatory Bowel Disease
Actuated Medical, Inc.
Lead sponsor
National Institutes of Health (NIH)
Collaborator