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