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

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Status

Not yet enrolling

Conditions

Adenoma Colon Polyp

Adenoma Colon

Treatments

Device: EndoTEM resection platform and technique

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07146165

S00830

Details and patient eligibility

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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