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

NCT07146165 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ovesco Endoscopy AG

    collaborator INDUSTRY

  • Tuebingen Scientific Medical GmbH

    collaborator UNKNOWN

  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

    lead OTHER

Principal Investigators

  • Arthur Schmidt, Prof. Dr. med. · Robert Bosch Krankenhaus GmbH

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146165 on ClinicalTrials.gov