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
N/A
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
Researchers are evaluating the use of the EndoTEM system during endoscopic removal of polyps in the distal colon, specifically adenomas or early carcinomas larger than 2 cm in the rectum or distal sigmoid colon. The study aims to determine if this new device enables complete polyp resection and is safe to use. The trial is conducted by Robert Bosch Gesellschaft fcr Medizinische Forschung mbH (RBMF) and focuses on feasibility and safety outcomes. Participants will undergo polyp removal using the EndoTEM system, a flexible port that allows insertion of a second instrument alongside the endoscope. This device includes a curved rigid grasping instrument with a rotatable and angled 2 cm tip. The procedure involves endoscopic submucosal dissection performed routinely with this system. There are no additional comparison groups or placebo treatments. Throughout the study, participants will complete questionnaires about fecal continence and quality of life before and after the procedure. Researchers will monitor technical success from the initial resection to a follow-up endoscopy after six months. They will also assess resection rates, procedure duration, complications, need for surgery, and recurrence during follow-ups up to six months. Standard clinical care is maintained before, during, and after the intervention, with total participation lasting at least six months.
CONDITIONS
Brief 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 or less
- Distance to the anocutaneous line greater than 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo the EndoTEM system procedure for routine endoscopic en bloc resection using endoscopic submucosal dissection.
1 visit (in-person)
Duration - 3 to 6 months
Participants are monitored for complications and recurrence after the procedure with follow-up endoscopy.
1 follow-up visit (in-person) approximately 6 months after the procedure
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
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