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

RecruitingNAAges 18 Years - anyAllRobert Bosch Gesellschaft für Medizinische Forsch…
NCT07146165 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Individual medical assessment required for patients taking anticoagulant medication, in accordance with current ESGE guidelines * Pregnancy or breastfeeding * Vulnerable individuals
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What it tests

  • EndoTEM resection platform and technique
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Where

3 sites
Universitätsklinikum Freiburg, Klinik für Innere Medizin II
Freiburg im Breisgau, Germany
RKH Klinikum Ludwigsburg
Ludwigsburg, Germany
Robert Bosch Krankenhaus GmbH
Stuttgart, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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