Status:
NOT_YET_RECRUITING
Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
Lead Sponsor:
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Collaborating Sponsors:
Ovesco Endoscopy AG
Tuebingen Scientific Medical GmbH
Conditions:
Adenoma Colon Polyp
Adenoma Colon
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07146165
Start Date
August 1 2025
End Date
August 1 2028
Last Update
August 28 2025
Active Locations (3)
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1
Universitätsklinikum Freiburg, Klinik für Innere Medizin II
Freiburg im Breisgau, Germany, 79106
2
RKH Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
3
Robert Bosch Krankenhaus GmbH
Stuttgart, Germany, 70376