for patients

Interested in participating in the study?

Bypass therapy for diabetes with obesity without surgery.

A SPECIAL OPPORTUNITY.

TDC has developed a tube bypass that can be inserted into the stomach outlet on an outpatient basis during a gastroscopy (under sedation) and left in place for 6 months. The mechanism of action is similar to that of bypass surgery, but it does not require surgery and leaves no permanent changes.

This therapy is particularly suitable for people with type 2 diabetes and obesity. For the clinical trial, we are therefore looking for patients with a BMI > of 30 or higher and poorly controlled HbA1c > of 7.0 or higher.
As part of the study, the sponsor will cover all costs, and participants will receive intensive care for up to 4 weeks after the procedure. Eight hospitals nationwide are participating in the study.

Do you have diabetes and are you overweight?

Various treatment options have already been discussed with you. A new option that was not previously available is endoscopic treatment using a film bypass, the Trans-Duodenal Barrier.

Trans-Duodenal Barrier – What Is It?

Das ist ein 60 cm langes, sehr dünnwandiges Schlauchsystem, das im Rahmen einer Magen-spiegelung für die Dauer von 6 Monaten in ihren Magenausgang und den oberen Dünndarm eingesetzt und später auf dem gleichen Wege wieder entfernt wird.

Es schafft eine Situation, wie sie aus der Chirurgie und von einem Vorläuferprodukt her bekannt und bewährt ist, jedoch ohne Operation und ohne bleibende Veränderungen in Ihrem Körper.

Trans-Duodenal Barrier – How Does It Work?

Das ist ein 60 cm langes, sehr dünnwandiges Schlauchsystem, das im Rahmen einer Magen-spiegelung für die Dauer von 6 Monaten in ihren Magenausgang und den oberen Dünndarm eingesetzt und später auf dem gleichen Wege wieder entfernt wird.

Es schafft eine Situation, wie sie aus der Chirurgie und von einem Vorläuferprodukt her bekannt und bewährt ist, jedoch ohne Operation und ohne bleibende Veränderungen in Ihrem Körper.

Participating in a study—what does that mean for me?

To participate in the study, you must carefully read and sign the informed consent form. In addition to a pre-study examination, the insertion of the TD-Barrier via gastroscopy, and its removal, you will be asked to come to the clinic for three follow-up examinations. Four weeks after removal, you will be contacted by phone to discuss your condition.

What are the risks?

Since this is a new type of product, there is not yet sufficient clinical experience with it. Possible complications include the implant slipping out of place, pain, or severe, persistent nausea. In all of these cases, the implant must be removed endoscopically. (More detailed information can be found in the informed consent form.)

What are the benefits for me?

Based on previous experience, a positive effect on your metabolism—particularly on diabetes management—is very likely. Weight loss is also expected. Study participants generally have the advantage that their treatment is monitored very closely. Participation in the study is free of charge for you; your treatment and travel expenses will be covered by the manufacturer of the TD-Barrier.

What should I keep in mind during treatment?

Zwei Wochen nach der Behandlung dürfen Sie nur Flüssigkeiten zu sich nehmen, dann zwei Wochen passierte Kost. Auch danach müssen Sie gut kauen und reichlich trinken. Bei akut auftretenden Problemen bitten wir Sie, unverzüglich Ihr Studienzentrum aufzusuchen.

Are you interested in participating?
Please contact one of the participating clinics directly: