NCT07146165

Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenoma Colon Polyp
• Adenoma Colon

Interventions

Type	Name	Description
DEVICE	EndoTEM resection platform and technique	EndoTEM is a flexible transanally introduced port system that allows the insertion of a second instrument alongside the flexible endoscope. A curved rigid grasping instrument has been developed, with a 2 cm long tip that can be rotated and angled in all directions.

Timeline

• Start date: 2025-10-02
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2025-08-28
• Last updated: 2026-03-31

Locations

3 sites across 1 country: Germany