Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity (NCT07417683) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity
Germany126 participantsStarted 2026-03
Plain-language summary
Approval study Trans-Duodenal Barrier The goal of this clinical trial is to determin the safety and performance of the newly developed Trans-Duodenal Barrier in adult Tryp 2 diabetic and obese patients.
The Trans-Duodenal Barrier is an endoscopic implant which can be placed to the gastric outlet and the upper small bowel by interventional endoscopy. It consists of a 60 cm long foil tube , a transpyloric shaft and and two ringlike balloons to fix it at the pylorus. It will be removed after 6 months via gastroscopy.
The main questions it aims to answer are:
* Does the Trans-Duodenal Barrier lower the HbA1c of the participants ?
* How frequent are adverse side effects related to the device?
* How much ist the excessive wight loss of treated patients ?
* Show patients with Metabolic assiociated Hepatosteatitis (MASH) improvements in liver elasticity (elastography) ? Researchers implant the Trans-Duodenal Barrier to enclosed patients and follow up them till 4 weeks after explantation.
Participants will:
* Get the Trans-Duodenal Barrier as an implant for 6 moths
* Visit the clinic 3 times in the implant period and once for explant.
* Receive a telefon interview 4 weeks after explant
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Obese patients with type 2 diabetes mellitus,
* Age ≥ 18 years,
* The patient is able to understand the nature, significance, and scope of the clinical trial (MPDG §28),
* The patient has been informed and all written consents from the patient are available.
Exclusion Criteria:
* The patient is mentally incapable of understanding the nature, objectives, or possible consequences of the clinical trial.
* The patient is unwilling or unable to follow postoperative instructions.
* The patient has been placed in an institution by court order or official order (MPDG §27).
* The patient lives more than 100 km from the treatment site.
* Pregnancy.
* The patient is participating in another clinical trial in the field of diabetes management or metabolic syndrome.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Main Outcome Measure HbA1c reduction
Timeframe: Improvement in 6 Month device implant time
2
Wight control
Timeframe: Outcome after 6 months device implant time