Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity
LuST
Leistung Und Sicherheit Des Trans-Duodenal Barrier (LuST)
2 other identifiers
interventional
126
1 country
8
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 18, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
February 18, 2026
February 1, 2026
2 years
February 10, 2026
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Main Outcome Measure HbA1c reduction
The HbA1c reduction shall exceed 0,8 in average
Improvement in 6 Month device implant time
Wight control
Excessive Body Wight reduction in device implant time
Outcome after 6 months device implant time
Secondary Outcomes (1)
Safety of the Trans-Duodenal Barrier
between implant and 4 weeks after explant (6 months after implant)
Other Outcomes (1)
Liver elasticity
device implant time 6 months
Study Arms (1)
Treatment with endoscopic implant of the investigational device
EXPERIMENTALThe decive will be implanted under sedation with the help of a standard flexible gastroscope. By filling the ringlike ballons with 62 ccm saline solution it will be fixed at the gastric oulet. After 6 months it will be removed by puncture and evacuation of the ballons and removal with a standard foreighn body forceps.
Interventions
The implant will be placed under sedation with the help of an standard flexible gastroscope. It will be fixed by fluid injection into ringlike ballons and place the device at the gastric outlet. After 6 months it will be removed by punction and evacuation of the ballons and extraction with a standard endoscopy foreighn body grasper.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trans-Duodenal Concepts GmbHlead
- novineon CRO GmbHcollaborator
- VDI Technologiezentrumcollaborator
Study Sites (8)
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
Sozialstiftung Bamberg
Bamberg, Bavaria, 96049, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Knappschaft Kliniken Universitätsklinikum Bochum GmbH Medizinische Klinik
Bochum, North Rhine-Westphalia, 44892, Germany
Städtisches Klinikum Dresden
Dresden, Saxony, 01067, Germany
University of Leipzig Medical Center, Department of Oncology, Gastroenterology, Hepatology and Pneumology
Leipzig, Saxony, 04103, Germany
Klinikum St. Georg Leipzig
Leipzig, Saxony, 04129, Germany
Charite Universitätmedizin Berlin CVK
Berlin, 13353, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Reissfelder, MD Prof.
University of Heidelberg, Medical Center Mannheim, Surgical Department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 18, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual patient data remains at the trial centers and is not transmitted to the CRO or the sponsor. The evaluation is based on pseudonymized data. Separate data processing agreements have been concluded between the trial centers and the study sponsor to ensure data security and confidentiality.