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Clinical Trials in Germany / NCT07146165
Recruiting Not applicable

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

NCT07146165 · tracked via the Priya Life Science Germany tracker
Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Phase
Not applicable
Started
2025-10-02
Last updated
2026-03-31

Condition(s) studied

Adenoma Colon PolypAdenoma Colon

Investigational drug(s) / intervention(s)

EndoTEM resection platform and technique

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Technical success of the endoscopic resection — From the endoscopic resection to the follow-up endoscopy after 6 months.
    Macroscopically complete resection.

Trial sites (3)

FacilityCityRegionStatus
Universitätsklinikum Freiburg, Klinik für Innere Medizin II Freiburg im Breisgau Germany Not Yet Recruiting
RKH Klinikum Ludwigsburg Ludwigsburg Germany Not Yet Recruiting
Robert Bosch Krankenhaus GmbH Stuttgart Germany Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07146165 on ClinicalTrials.gov ↗ ← All trials in Germany