NCT07146165 Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
| NCT ID | NCT07146165 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) |
| Condition | Adenoma Colon Polyp |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-10-02 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Arthur Schmidt, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
Robert Bosch Krankenhaus GmbH
Frequently Asked Questions
Who can join the NCT07146165 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adenoma Colon Polyp. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07146165 currently recruiting?
Yes, NCT07146165 is actively recruiting participants. Visit ClinicalTrials.gov or contact Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) to inquire about joining.
Where is the NCT07146165 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany, Ludwigsburg, Germany, Stuttgart, Germany.
Who is sponsoring the NCT07146165 clinical trial?
NCT07146165 is sponsored by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF). The principal investigator is Arthur Schmidt, Prof. Dr. med. at Robert Bosch Krankenhaus GmbH. The trial plans to enroll 30 participants.