Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrans-Duodenal Concepts GmbH
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
endoscopic implant
DeviceThe 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.
Treatment groups
126 Participants
are divided into 1 treatment groupGroup A: Treatment with endoscopic implant of the investigational deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Main Outcome Measure HbA1c reduction
The HbA1c reduction shall exceed 0,8 in average
Time frame
Improvement in 6 Month device implant time2
Wight control
Excessive Body Wight reduction in device implant time
Time frame
Outcome after 6 months device implant timeSecondary outcomes
1
Safety of the Trans-Duodenal Barrier
Frequency and Severity of SAEs
Time frame
between implant and 4 weeks after explant (6 months after implant)Other outcomes
1
Liver elasticity
Measurement of Liver stiffness by elastography
Time frame
device implant time 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Trans-Duodenal Concepts GmbH
Lead sponsor
novineon CRO GmbH
Collaborator
VDI Technologiezentrum
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: