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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRobert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • EndoTEM resection platform and technique

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Lead sponsor

Ovesco Endoscopy AG

Collaborator

Tuebingen Scientific Medical GmbH

Collaborator