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Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-10-02
Completion Date
2028-08
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
EndoTEM resection platform and technique
EndoTEM 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.
Locations (3)
Universitätsklinikum Freiburg, Klinik für Innere Medizin II
Freiburg im Breisgau, Germany
RKH Klinikum Ludwigsburg
Ludwigsburg, Germany
Robert Bosch Krankenhaus GmbH
Stuttgart, Germany