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

Adenoma Colon Adenoma Colon Polyp

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

Inclusion Criteria3

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 Criteria7

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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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.