Testing an Endoscopic Implant in the Gut for Type 2 Diabetes With Obesity
Tests a removable gut implant in adults with type 2 diabetes and obesity.
Plain-language title generated from the registry record
Registry title: Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity
Key facts
- Where
- Bamberg, Berlin, Bochum, Dresden, Leipzig, Mannheim, and Würzburg, GermanySee the 8 sites
Where in Germany
- Sozialstiftung BambergBamberg, GermanyNo longer taking part
- Charite Universitätmedizin Berlin CVKBerlin, GermanyNo longer taking part
- Knappschaft Kliniken Universitätsklinikum Bochum GmbH Medizinische KlinikBochum, GermanyNo longer taking part
- Städtisches Klinikum DresdenDresden, GermanyNo longer taking part
- Klinikum St. Georg LeipzigLeipzig, GermanyNo longer taking part
- University of Leipzig Medical Center, Department of Oncology, Gastroenterology, Hepatology and PneumologyLeipzig, GermanyNo longer taking part
- Universitätsmedizin MannheimMannheim, GermanyNo longer taking part
- Universitätsklinikum WürzburgWürzburg, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Trans-Duodenal Concepts GmbH
- Trial code
- NCT07417683
- Record updated
- 18 February 2026
- Original description
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.Read full original descriptionShow less
Leistung Und Sicherheit Des Trans-Duodenal Barrier (LuST)
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
Inclusion: 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: The patient is participating in another clinical trial in the field of diabetes management or metabolic syndrome; 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.