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Recruiting NCT07146165

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

No phase Interventional Adenoma Colon Polyp Adenoma Colon

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EndoTEM resection platform and technique.
Who it may be relevant to
Registry conditions: Adenoma Colon Polyp, Adenoma Colon. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Primary outcome measures

  • Technical success of the endoscopic resection [Time frame: From the endoscopic resection to the follow-up endoscopy after 6 months.]
Secondary outcome measures (8)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Germany · 3 centers
  • Universitätsklinikum Freiburg, Klinik für Innere Medizin II — Freiburg im Breisgau
  • RKH Klinikum Ludwigsburg — Ludwigsburg
  • Robert Bosch Krankenhaus GmbH — Stuttgart

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

Identifiers

NCT: NCT07146165 · S00830

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗