NCT07146165

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Oct 2025Aug 2028

First Submitted

Initial submission to the registry

July 31, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

July 31, 2025

Last Update Submit

March 30, 2026

Conditions

Adenoma Colon PolypAdenoma Colon

Keywords

endoscopic submucosal dissectionendoscopic en bloc resectionEndoTEM systemendoscopic portsystemESD

Outcome Measures

Primary Outcomes (1)

  • Technical success of the endoscopic resection

    Macroscopically complete resection.

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

Secondary Outcomes (8)

  • R0 resection rate

    Assessed with a biopsy collected during the intervention.

  • En bloc resection rate

    Assessed during the intervention.

  • Duration of the procedure

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

  • Resection time

    From start of the resection until detachment of the specimen.

  • Resection speed

    Assessed during the intervention.

  • +3 more secondary outcomes

Study Arms (1)

EndoTEM-System

EXPERIMENTAL

Utilization of the EndoTEM system in the performance of routine endoscopic en bloc resection using endoscopic submucosal dissection.

Device: EndoTEM resection platform and technique

Interventions

EndoTEM resection platform and techniqueDEVICE

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.

Also known as: endoscopic portsystem
EndoTEM-System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitätsklinikum Freiburg, Klinik für Innere Medizin II

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

RKH Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

NOT YET RECRUITING

Robert Bosch Krankenhaus GmbH

Stuttgart, 70376, Germany

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Arthur Schmidt, Prof. Dr. med.

    Robert Bosch Krankenhaus GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 28, 2025

Study Start

October 2, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)