Study of the EndoTEM System for Safe and Effective Removal of Large Polyps in the Rectum and Lower Sigmoid Colon Using Endoscopic Submucosal Dissection

What this Trial Is About

Researchers are evaluating the use of the EndoTEM system during endoscopic removal of polyps in the distal colon, specifically adenomas or early carcinomas larger than 2 cm in the rectum or distal sigmoid colon. The study aims to determine if this new device enables complete polyp resection and is safe to use. The trial is conducted by Robert Bosch Gesellschaft fcr Medizinische Forschung mbH RBMF and focuses on feasibility and safety outcomes. Participants will undergo polyp removal using the EndoTEM system, a flexible port that allows insertion of a second instrument alongside the endoscope. This device includes a curved rigid grasping instrument with a rotatable and angled 2 cm tip. The procedure involves endoscopic submucosal dissection performed routinely with this system. There are no additional comparison groups or placebo treatments. Throughout the study, participants will complete questionnaires about fecal continence and quality of life before and after the procedure. Researchers will monitor technical success from the initial resection to a follow-up endoscopy after six months. They will also assess resection rates, procedure duration, complications, need for surgery, and recurrence during follow-ups up to six months. Standard clinical care is maintained before, during, and after the intervention, with total participation lasting at least six months.

Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)