EndoBarrier Register Deutschland-Safety and Efficacy of the Endoscopic Duodenal-Jejunal Bypass Sleeve

Study Overview
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Brief Summary
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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
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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.

Official Title
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EndoBarrier Register Deutschland

Conditions
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Obesity, Diabetes Mellitus

Intervention / Treatment
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* Device: Insertion of EndoBarrier for approximately one year


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical decision for treatment with EndoBarrier informed consent for registry participation Exclusion Criteria: Patients not meeting the inclusion criteria age < 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EndoBarrier<br>All patients with EndoBarrier treatment | Device: Insertion of EndoBarrier for approximately one year<br>* Insertion of EndoBarrier for approximately one year then explantation and follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Adverse events associated to implantation, explantation or insertion of EndoBarrier such as bleeding, liver abscess, abdominal pain, nausea, vomiting, duodenal ulcers, duodenal perforation | From Implantation to at least 2 years follow up | 
| Improvement of subjective Arthropathia | Qualitative Measurement of improvement of subjective Arthropathia, no scale is used | From Implantation to at least 2 years follow up | 
| 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 | 
| 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 | 
| 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 | Ferritin will be measured | From Implantation to at least 2 years follow up | 
| 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 |