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NCT Number: NCT07146165

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

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.

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Key information

Conditions

Adenoma Colon Polyp Adenoma Colon

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Freiburg, Klinik für Innere Medizin II, Freiburg im Breisgau, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EndoTEM resection platform and technique

Device

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.

Other names: endoscopic portsystem

Primary outcomes

  1. Technical success of the endoscopic resection

    Time frame: From the endoscopic resection to the follow-up endoscopy after 6 months.

    Macroscopically complete resection.

Secondary outcomes

  1. R0 resection rate

    Time frame: Assessed with a biopsy collected during the intervention.

    Histological complete resection.

  2. En bloc resection rate

    Time frame: Assessed during the intervention.

    Endoscopic removal of the polyp in one intact piece, including any necessary surrounding tissue.

  3. Duration of the procedure

    Time frame: From endoscope insertion until the end of procedure including supplementary and prophylactic interventions.

  4. Resection time

    Time frame: From start of the resection until detachment of the specimen.

  5. Resection speed

    Time frame: Assessed during the intervention.

    Resected area per minute (mm²/min).

  6. Periprocedural complications

    Time frame: Complications that occur during or immediately around the intervention (until 3-6 months post-intervention).

  7. Requirement for surgical intervention

    Time frame: During the endoscopic submucosal dissection.

  8. Rate of recurrence

    Time frame: Assessed during follow-up endoscopy 3-6 months post-intervention.

Sponsors and collaborators

Lead sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Other

Collaborators

  • Ovesco Endoscopy AG
  • Tuebingen Scientific Medical GmbH

Registry information

Acronym: EndoTEM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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