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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Eligibility

Primary outcome measure(s)

• Main Outcome Measure HbA1c reduction — Improvement in 6 Month device implant time
  The HbA1c reduction shall exceed 0,8 in average
• Wight control — Outcome after 6 months device implant time
  Excessive Body Wight reduction in device implant time

Trial sites (8)

Other trials for the same condition