EndoBarrier Register Deutschland-Safety and Efficacy of the Endoscopic Duodenal-Jejunal Bypass Sleeve
- Conditions
- Diabetes MellitusObesity
- Interventions
- Device: Insertion of EndoBarrier for approximately one year
- Registration Number
- NCT02731859
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
The purpose of this study ist to determine long-term safety and efficacy in weight reduction and improvement of diabetes mellitus of the temporary, endoscopic duodenal-jejunal bypass-sleeve EndoBarrier® in a national registry.
- Detailed Description
Long-term data are collected by approximately 30 German centers. An electronic Case-Report-Form (eCRF) was designed to collect relevant pre-specified items by the Clinical Trial Center North (CTC). All German sites that have implanted EndoBarrier® since 2010 were invited to provide patient results. Data-acquisition is projected to a period of 5 years and a maximum of 1000 patients. An extension of data-acquisition is planned.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- clinical decision for treatment with EndoBarrier
- informed consent for registry participation
- Patients not meeting the inclusion criteria
- age < 18
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EndoBarrier Insertion of EndoBarrier for approximately one year All patients with EndoBarrier treatment
- Primary Outcome Measures
Name Time Method Reduction of HbA1C From Implantation to at least 2 years follow up Reduction of Antidiabetic Medication From Implantation to at least 2 years follow up Excess weight loss From Implantation to at least 2 years follow up Reduction of BMI From Implantation to at least 2 years follow up Weight reduction From Implantation to at least 2 years follow up
- Secondary Outcome Measures
Name Time Method Reduction of fasting insulin From Implantation to at least 2 years follow up Reduction of fasting C-Peptide From Implantation to at least 2 years follow up Reduction of systolic blood pressure From Implantation to at least 2 years follow up Reduction of diastolic blood pressure From Implantation to at least 2 years follow up Reduction of antihypertensive medication From Implantation to at least 2 years follow up Reduction of total cholesterol From Implantation to at least 2 years follow up Reduction of LDL-cholesterol From Implantation to at least 2 years follow up Number of participants with treatment-related adverse events From Implantation to at least 2 years follow up Adverse events associated to implantation, explantation or insertion of EndoBarrier such as bleeding, liver abscess, abdominal pain, nausea, vomiting, duodenal ulcers, duodenal perforation
Improvement of subjective Arthropathia From Implantation to at least 2 years follow up Qualitative Measurement of improvement of subjective Arthropathia, no scale is used
Smoking Status From Implantation to at least 2 years follow up Time of implantation and explantation From Implantation to at least 2 years follow up Reduction of fasting glucose From Implantation to at least 2 years follow up Increase of HDL-cholesterol From Implantation to at least 2 years follow up Reduction of fasting triglycerides From Implantation to at least 2 years follow up Reduction of antihyperlipidemic medication From Implantation to at least 2 years follow up Reduction of 25OHD3 From Implantation to at least 2 years follow up Reduction of Calcium From Implantation to at least 2 years follow up Reduction of Ferritin From Implantation to at least 2 years follow up Ferritin will be measured
Reduction of Hemoglobin From Implantation to at least 2 years follow up Reduction of Vitamin B12 From Implantation to at least 2 years follow up Reduction of Albumin From Implantation to at least 2 years follow up Reduction of Folic acid From Implantation to at least 2 years follow up Reduction of Vitamin B1 From Implantation to at least 2 years follow up Reduction of Vitamin B6 From Implantation to at least 2 years follow up Reduction of CK From Implantation to at least 2 years follow up Reduction of AST From Implantation to at least 2 years follow up Reduction of ALT From Implantation to at least 2 years follow up Reduction of hsCRP From Implantation to at least 2 years follow up Duration of implantation process of the EndoBarrier in minutes From Implantation to at least 2 years follow up Duration of ithe explantation process of the EndoBarrier in minutes From Implantation to at least 2 years follow up Reduction of waist circumference From Implantation to at least 2 years follow up Reduction of daily caloric intake From Implantation to at least 2 years follow up
Trial Locations
- Locations (11)
St. Martinus Krankenhaus Düsseldorf
🇩🇪Düsseldorf, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Donau-Ries Klinik Donauwörth
🇩🇪Donauwörth, Germany
Klinikum Forchheim
🇩🇪Forchheim, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Evangelisches Krankenhaus Köln-Weyertal
🇩🇪Köln, Germany
Petrus Krankenhaus Wuppertal
🇩🇪Wuppertal, Germany
Universitätsklinikum Freiburg- Abt. Innere Medizin II
🇩🇪Freiburg, Germany
Marienhospital Gelsenkirchen
🇩🇪Gelsenkirchen, Germany
Krankenhaus Emmaus-Niesky
🇩🇪Niesky, Germany
Elisabeth Klinikum Schmalkalde
🇩🇪Schmalkalden, Germany