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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2028-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Adenoma Colon Polyp Adenoma Colon

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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EndoTEM-System

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

Group Type EXPERIMENTAL

EndoTEM resection platform and technique

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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endoscopic portsystem

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No