Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07417683

Opening soonNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionTyp 2 Diabetes, Obesity, Obesity Type 2 Diabetes Mellitus, MASH

Full registry criteria

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.

Treatments and study arms

endoscopic implant

Device

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.