RecruitingNot ApplicableNCT07146165

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)

Enrollment

30 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called EndoTEM resection platform and technique for people with adenoma colon and adenoma colon polyp. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndoTEM 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

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NCT07146165


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