Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity

Starting soon · Not applicable

Conditions studied: Typ 2 Diabetes, Obesity, Obesity Type 2 Diabetes Mellitus, MASH

In brief

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

Key facts

Study ID

NCT07417683

Run by

Trans-Duodenal Concepts GmbH

People needed

126

Starts

2026-03-01

Expected to finish

2028-04-01

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Universitätsmedizin Mannheim — Mannheim, Baden-Wurttemberg, Germany
• Sozialstiftung Bamberg — Bamberg, Bavaria, Germany
• Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany
• Knappschaft Kliniken Universitätsklinikum Bochum GmbH Medizinische Klinik — Bochum, North Rhine-Westphalia, Germany
• Städtisches Klinikum Dresden — Dresden, Saxony, Germany
• University of Leipzig Medical Center, Department of Oncology, Gastroenterology, Hepatology and Pneumology — Leipzig, Saxony, Germany
• Klinikum St. Georg Leipzig — Leipzig, Saxony, Germany
• Charite Universitätmedizin Berlin CVK — Berlin, Germany

Full record on ClinicalTrials.gov

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