Actively Recruiting
Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
Led by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) · Updated on 2026-03-31
30
Participants Needed
3
Research Sites
147 weeks
Total Duration
On this page
Sponsors
R
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Lead Sponsor
O
Ovesco Endoscopy AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Universitätsklinikum Freiburg, Klinik für Innere Medizin II
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
2
RKH Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
Not Yet Recruiting
3
Robert Bosch Krankenhaus GmbH
Stuttgart, Germany, 70376
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here