Adenoma Colon PolypEndoTEMNCT07146165
Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
A study testing EndoTEM resection platform and technique in people with Adenoma Colon Polyp and Adenoma Colon, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 3 sites in Germany.
Trial 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.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoma Colon Polyp, Adenoma Colon
- What is being tested?
- EndoTEM resection platform and technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesGermany
- Study dates
- 2 Oct 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitätsklinikum Freiburg, Klinik für Innere Medizin II
Freiburg im Breisgau, 79106
Laura Weber, +49 76127032613, med.2-gi-study@uniklinik-freiburg.de
Armin Küllmer, PD. Dr. med.
- Not yet recruiting
RKH Klinikum Ludwigsburg
Ludwigsburg, 71640
Maike Schwidder, Dr. rer. nat., +497141 99 97543, maike.schwidder@rkh-gesundheit.de
Andreas Wannhoff, PD Dr. med
- Recruiting
Robert Bosch Krankenhaus GmbH
Stuttgart, 70376
Jasmin Ketel, +49 71181017704, jasmin.ketel@rbk.de
Martin Schich, Dr. med., 071181012781, martin.schich@rbk.de
About this study
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:
Read more
- 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
- Being tested
- EndoTEM resection platform and technique
- Keywords
- endoscopic submucosal dissection, endoscopic en bloc resection, EndoTEM system, endoscopic portsystem, ESD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoTEM resection platform and techniqueDevice
Also called endoscopic portsystem
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.
| Study group | Role | What they receive |
|---|---|---|
| EndoTEM-System | Experimental | Utilization of the EndoTEM system in the performance of routine endoscopic en bloc resection using endoscopic submucosal dissection. Receives: Device: EndoTEM resection platform and technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of the endoscopic resection
Macroscopically complete resection.
Measured: From the endoscopic resection to the follow-up endoscopy after 6 months.
Secondary outcomes (8)
R0 resection rate
Histological complete resection.
Measured: Assessed with a biopsy collected during the intervention.
En bloc resection rate
Endoscopic removal of the polyp in one intact piece, including any necessary surrounding tissue.
Measured: Assessed during the intervention.
Duration of the procedure
Measured: From endoscope insertion until the end of procedure including supplementary and prophylactic interventions.
Resection time
Measured: From start of the resection until detachment of the specimen.
Resection speed
Resected area per minute (mm²/min).
Measured: Assessed during the intervention.
Periprocedural complications
Measured: Complications that occur during or immediately around the intervention (until 3-6 months post-intervention).
Requirement for surgical intervention
Measured: During the endoscopic submucosal dissection.
Rate of recurrence
Measured: Assessed during follow-up endoscopy 3-6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start2 Oct 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoma Colon PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Sponsor type
- University, hospital or other
- Collaborators
- Ovesco Endoscopy AG, Tuebingen Scientific Medical GmbH
- Responsible party
- Sponsor
- Investigators
- Arthur Schmidt, Prof. Dr. med., Principal investigator, Robert Bosch Krankenhaus GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146165
- Sponsor's protocol ID
- S00830
- Acronym
- EndoTEM
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueller J, Miedtke V, Kuellmer A et al. A novel endoscopic technique and device for bimanual rectosigmoidal ESD. Endoscopy 2023; 55(S02): 264 - 264. doi:10.1055/s-0043-1765725
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
- ClinicalTrials.gov ID
- NCT07146165
- Acronym / sponsor ID
- EndoTEM / S00830
- Conditions
- Adenoma Colon Polyp, Adenoma Colon
- Keywords
- endoscopic submucosal dissection, endoscopic en bloc resection, EndoTEM system, endoscopic portsystem, ESD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)University, hospital or other
- Collaborators
- Ovesco Endoscopy AG, Tuebingen Scientific Medical GmbH
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoTEM-System | Experimental | Device: EndoTEM resection platform and techniqueUtilization of the EndoTEM system in the performance of routine endoscopic en bloc resection using endoscopic submucosal dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoTEM resection platform and techniqueAlso: endoscopic portsystemEndoTEM 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. | Device | EndoTEM-System |
Primary outcome
Technical success of the endoscopic resection
Time frame: From the endoscopic resection to the follow-up endoscopy after 6 months.
Macroscopically complete resection.
8 secondary outcomes
R0 resection rate
Time frame: Assessed with a biopsy collected during the intervention.
En bloc resection rate
Time frame: Assessed during the intervention.
Duration of the procedure
Time frame: From endoscope insertion until the end of procedure including supplementary and prophylactic interventions.
Resection time
Time frame: From start of the resection until detachment of the specimen.
Resection speed
Time frame: Assessed during the intervention.
Periprocedural complications
Time frame: Complications that occur during or immediately around the intervention (until 3-6 months post-intervention).
Requirement for surgical intervention
Time frame: During the endoscopic submucosal dissection.
Rate of recurrence
Time frame: Assessed during follow-up endoscopy 3-6 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- BackgroundMueller J, Miedtke V, Kuellmer A et al. A novel endoscopic technique and device for bimanual rectosigmoidal ESD. Endoscopy 2023; 55(S02): 264 - 264. doi:10.1055/s-0043-1765725
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Universitätsklinikum Freiburg, Klinik für Innere Medizin II
Freiburg im Breisgau, Germany
Arthur Schmidt, Prof. Dr. med. principal investigator
Robert Bosch Krankenhaus GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoTEM resection platform and technique in people with Adenoma Colon Polyp and Adenoma Colon, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of the endoscopic resection (time frame: From the endoscopic resection to the follow-up endoscopy after 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07146165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.