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New treatment option for Adenoma Colon Polyp
Official title Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
ClinicalTrials.gov ID: NCT07146165
What this study is testing
- What it's testing
- 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)?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Freiburg im Breisgau, Germany
- Ludwigsburg, Germany
- Stuttgart, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Freiburg im Breisgau, Germany; Ludwigsburg, Germany; Stuttgart, Germany. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.