The goal of this clinical trial is to determine whether the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon is feasible and safe.
The main questions it aims to answer are:
* Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon feasible (i.e., does it enable complete resection of the polyp)? * Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon safe?
Participants will:
* be treated with the EndoTEM system during the endoscopic submucosal dissection of polyps in the distal colon. * answere questionnaires on fecal continence and quality of life before and after the intervention. * be treated following standard clinical procedures before, during and after the endoscopic removal.
Availability of written informed consent from the patient
Age > 18 years
Adenoma or early carcinoma > 2 cm in the rectum or distal sigmoid colon with indication for endoscopic en bloc resection using endoscopic submucosal dissection
Informed consent not possible (e.g., language barrier)
Stenoses or fistulas in the anal region
Distance to the anocutaneous line ≤ 2 cm
Distance to the anocutaneous line > 20 cm
Single group
EndoTEM resection platform and technique
DeviceEndoTEM is a flexible transanally introduced port system that allows the insertion of a second instrument alongside the flexible endoscope. A curved rigid grasping instrument has been developed, with a 2 cm long tip that can be rotated and angled in all directions.
Technical success of the endoscopic resection
Macroscopically complete resection.
R0 resection rate
Histological complete resection.
En bloc resection rate
Endoscopic removal of the polyp in one intact piece, including any necessary surrounding tissue.
Duration of the procedure
Resection time
Click on the lead sponsor to view all of their trials.
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Lead sponsor
Ovesco Endoscopy AG
Collaborator
Tuebingen Scientific Medical GmbH
Collaborator
