Bi‑manual EndoTEM system to remove polyps from the rectum and lower sigmoid colon
Official title: Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
Run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) · NCT07146165 · Data updated 2026-11-12
This will test whether the EndoTEM system can safely and completely remove large rectal and distal sigmoid polyps in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) Academic / other |
| Locations | 3 sites (Freiburg im Breisgau and 2 other locations) |
| Status | Recruiting |
| Started | October 2, 2025 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT07146165 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with an adenoma or early carcinoma >2 cm located in the rectum or distal sigmoid colon who are eligible for endoscopic submucosal dissection and can provide written informed consent.
✕Probably not a fit
Patients with anal stenoses or fistulas, lesions within 2 cm or beyond 20 cm of the anocutaneous line, those unable to consent, pregnant or breastfeeding individuals, and some patients on anticoagulant therapy may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional pilot uses the EndoTEM bi‑manual resection platform during endoscopic submucosal dissection to remove adenomas or early carcinomas larger than 2 cm in the rectum or distal sigmoid colon. Patients receive standard peri-procedural care and complete questionnaires on fecal continence and quality of life before and after the intervention. The study documents whether en bloc (one‑piece) resection is achieved and carefully monitors for procedure‑related complications and safety events. Procedures are performed at participating German hospitals using the EndoTEM technique.
Why it matters
Potential benefit: If successful, EndoTEM could allow safer, more complete endoscopic one-piece removal of large distal colon polyps and reduce the need for surgical resection.
How similar studies have gone: Endoscopic submucosal dissection is an established technique for en bloc resection, but the bi‑manual EndoTEM platform is a novel device with limited published clinical data so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Robert Bosch Krankenhaus GmbH
Stuttgart, Germany Recruiting -
Universitätsklinikum Freiburg, Klinik für Innere Medizin II
Freiburg im Breisgau, Germany Not yet recruiting -
RKH Klinikum Ludwigsburg
Ludwigsburg, Germany Not yet recruiting
Study contacts
- Principal investigator: Arthur Schmidt, Prof. Dr. med. — Robert Bosch Krankenhaus GmbH
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.