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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Obesity Type 2 Diabetes Mellitus; MASH; Typ 2 Diabetes
• Intervention / Treatment: Device: endoscopic implant

Detailed Description

Title of the study Clinical study to investigate the performance and safety of the Trans-Duodenal Barrier (LuST) Short title LuST EUDAMED Single Identification Number (SIN) or CIV-ID To be determined Sponsor Trans-Duodenal Concepts GmbH Tannhäuserring 93 68199 Mannheim Tel georg.kaehler@transduodenal.com Manufacturer Trans-Duodenal Concepts GmbH Tannhäuserring 93 68199 Mannheim Tel Test product Trans-Duodenal Barrier (TDB®) Risk class II b Study director Prof. Dr. Christoph Reißfelder, Director of the University Surgical Clinic Mannheim Other study centers

1. Bamberg Social Foundation - Bamberg Clinic
2. Charité Berlin
3. University Hospital Bochum
4. Dresden Municipal Hospital
5. St. Georg Hospital, Leipzig
6. University Hospital Leipzig
7. University Hospital Mannheim
8. University Hospital Würzburg Statistics and database management pfm medical expert gmbh, Wankelstraße 60, 50996 Cologne Project management

Study contact:

Prof. Dr. Georg Kähler Trans-Duodenal Concepts GmbH Tannhäuserring 93 68199 Mannheim georg.kaehler@transduodenal.com Study design National, multicenter, non-randomized, prospective CE marking study at eight trial sites in Germany.

Data on the use of TDB® will be collected over a period of 28 weeks. The focus here is on the performance of the Trans-Duodenal Barrier as measured by the long-term diabetes value HbA1c, patient satisfaction (patient-reported outcome), and the complication rate.

Compliance with the current Declaration of Helsinki, DIN EN ISO 14155:2021-05, MDR (EU) 2017/745, and MPDG (May 12, 2021)

Study duration Total: 64 weeks Per patient: 28 weeks Recruitment phase: 36 weeks Follow-up examinations: 2, 6, 12, 24, and 28 weeks after implantation

Test product and procedure The TDB® is an endoscopically implantable medical device. The indications for the use of the TDB® are diseases associated with metabolic syndrome, in particular type II diabetes mellitus in conjunction with obesity and non-alcoholic liver disease. The TDB® is used for the endoscopic creation of a temporary reversible bypass situation in the duodenum and upper jejunum. The aim of using the TDB® is to prevent contact and absorption of nutrients in the duodenum and to prolong the feeling of satiety.

Planned number of patients 126 patients

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 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,
• Known allergies to polyurethanes and/or polyamides and/or methylene blue,
• Coagulation disorders (thrombocytes < 100,000; Quick < 65%),
• Previous surgery in the gastrointestinal tract
• Known adhesions in the abdominal cavity
• Acute gastrointestinal diseases
• Untreated psychosis, bulimia

Examinations

• Age, weight, height of the patient
• Metabolic parameters, HbA1c, satisfaction with diabetes treatment (questionnaire)
• Duration of implantation, technical success
• Incidence and severity of side effects, adverse events with the implant, and unexpected side effects from using the implant
• Medical measures to control them
• Explantation: duration, local findings in the former implant site

Study hypothesis The study hypothesis is that the Transduodenal Barrier will lead to an average reduction in HbA1c of at least 0.8% in six months. Example: HbA1c from 8.5% - 0.8% to 7.7%.

Case number calculation

The sample size was calculated on the basis of a one-sided t-test with paired samples, for which the following values and assumptions apply:

MCID: ∆ = 0.8 SD: σ = 2.5 Effect size: d = 0.32 Type I error: α = 0.01 (confidence level 0.99) Type II error: β = 0.2 (power P = 0.80) Type of test: one-sided t-test with paired samples. Expected dropout rate = 20%

Therefore, a sample size of 126 patients is required.

Missing values for primary endpoints in some included subjects due to subject withdrawal, missed visits, or protocol deviations will result in a lower number of patients and may thus compromise the efficiency of the study. An overall rate of ~20% is expected.

Primary study objective Improvement in HbA1c value by an average of at least 0.8%

Secondary study objectives

• Investigation of the frequency of adverse side effects (dislocation, need for premature removal of the implant)
• Determination of the rate of successfully treated patients (HbA1c reduction of at least 0.8%)
• Improvement in liver elasticity (elastography)
• Weight loss (excess weight loss (EWL))

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georg Kähler, MD, Prof.; Phone Number: +491797347734; Email: georg.kaehler@transduodenal.com
• Study Contact Backup: Name: Sabrina Rohrer, PhD; Phone Number: +49707198979133; Email: sabrina.rohrer@novineon.com

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charite Universitätmedizin Berlin CVK
    • Contact: Konstantinos Kouladouros, MD PhD; Phone Number: +4930450665318; Email: konstantinos.kouladouros@charite.de
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Universitätsmedizin Mannheim
      • Contact: Niki Taebi, B.Sc.; Phone Number: +496213834864; Email: niki.taebi@umm.de
  • Bavaria
    • Bamberg, Bavaria, Germany, 96049
      • Sozialstiftung Bamberg
      • Contact: Felix Gundling, MD, Prof.; Phone Number: +49951 503-13713; Email: felix.gundling@sozialstiftung-bamberg.de
    • Würzburg, Bavaria, Germany, 97080
      • Universitatsklinikum Wurzburg
      • Contact: Markus Brand, MD, PhD; Phone Number: +4993120140931; Email: Brand_M@ukw.de
  • North Rhine-Westphalia
    • Bochum, North Rhine-Westphalia, Germany, 44892
      • Knappschaft Kliniken Universitätsklinikum Bochum GmbH Medizinische Klinik
      • Contact: Ali Canbay, MD, Prof.; Phone Number: +4923429983416; Email: ali.canbay@ruhr-uni-bochum.de
  • Saxony
    • Dresden, Saxony, Germany, 01067
      • Stadtisches Klinikum Dresden
      • Contact: Matthias Kandler, MD; Phone Number: +493518562170; Email: matthias.kandler@klinikum-dresden.de
    • Leipzig, Saxony, Germany, 04103
      • University of Leipzig Medical Center, Department of Oncology, Gastroenterology, Hepatology and Pneumology
    • Leipzig, Saxony, Germany, 04129
      • Klinikum St. Georg Leipzig
      • Contact: Ingolf Schiefke, MD, Prof.; Phone Number: +493419094312

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment with endoscopic implant of the investigational device; The 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.

Device: endoscopic implant; 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.; Other Names: gastroduodenal bypass liner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the Trans-Duodenal Barrier	Frequency and Severity of SAEs	between implant and 4 weeks after explant (6 months after implant)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver elasticity	Measurement of Liver stiffness by elastography	device implant time 6 months

Collaborators and Investigators

• Sponsor: Trans-Duodenal Concepts GmbH
• Collaborators: novineon CRO GmbH; VDI Technologiezentrum
• Investigators: Principal Investigator: Christoph Reissfelder, MD Prof., University of Heidelberg, Medical Center Mannheim, Surgical Department

Publications and helpful links

Helpful Links

• Sponsors Homepage
• CROs Homepage

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: glycemic control; gastroduodenal liner; endoscopic implant; wight management
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy
• Other Study ID Numbers: TDB Approval study; CIV-25-06-053456 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No