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

NCT07417683 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-02-18

No results posted yet for this study

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

Conditions

  • Typ 2 Diabetes
  • Obesity
  • Obesity Type 2 Diabetes Mellitus
  • MASH

Interventions

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.

Sponsors & Collaborators

  • novineon CRO GmbH

    collaborator UNKNOWN

  • VDI Technologiezentrum

    collaborator UNKNOWN

  • Trans-Duodenal Concepts GmbH

    lead INDUSTRY

Principal Investigators

  • Christoph Reissfelder, MD Prof. · University of Heidelberg, Medical Center Mannheim, Surgical Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-03-31
Completion
2028-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07417683 on ClinicalTrials.gov