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New device aims to make colon polyp removal safer and more complete

NCT ID NCT07146165

Disease control Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called EndoTEM, which helps doctors use two instruments at once to remove large polyps from the lower colon. The goal is to see if it is safe and can remove the entire polyp in one piece. Thirty adults with large polyps or early cancer in the rectum or sigmoid colon will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EndoTEM resection platform and technique (a flexible port system for bi-manual endoscopic polyp removal)
What this could lead to
If successful, this could offer a safer, more effective way to remove large colon polyps without surgery, reducing the need for more invasive procedures.
What could go wrong
This is a small, early feasibility study with only 30 participants. The device may not work as expected or could cause complications like bleeding or perforation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

adenomatous colon polyp colon adenoma rectosigmoid carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenoma colon Adenoma colon polyp

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • RKH Klinikum Ludwigsburg

    NOT_YET_RECRUITING

    Ludwigsburg, 71640, Germany

  • Robert Bosch Krankenhaus GmbH

    RECRUITING

    Stuttgart, 70376, Germany

  • Universitätsklinikum Freiburg, Klinik für Innere Medizin II

    NOT_YET_RECRUITING

    Freiburg im Breisgau, 79106, Germany

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