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| Name | Class |
|---|---|
| Morphic Medical Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoBarrier | All patients with EndoBarrier treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion of EndoBarrier for approximately one year | Device | Insertion of EndoBarrier for approximately one year then explantation and follow-up |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with either Obesity and/or Diabetes mellitus who are treated with the EndoBarrier
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Hinz | Contact | 040/741020901 | ni.sauer@uke.de | |
| Nina Sauer | Contact | 01781642802 | ninasauer@ymail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jens Aberle | University hospital Hamburg, Endokrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Augsburg | Recruiting | Augsburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29504053 | Derived | Riedel N, Laubner K, Lautenbach A, Schon G, Schlensak M, Stengel R, Eberl T, Dederichs F, Aberle J, Seufert J. Trends in BMI, Glycemic Control and Obesity-Associated Comorbidities After Explantation of the Duodenal-Jejunal Bypass Liner (DJBL). Obes Surg. 2018 Aug;28(8):2187-2196. doi: 10.1007/s11695-018-3144-9. |
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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 |
| Evangelisches Krankenhaus Köln-Weyertal | Recruiting | Cologne | Germany |
|
| Donau-Ries Klinik Donauwörth | Recruiting | Donauwörth | Germany |
|
| St. Martinus Krankenhaus Düsseldorf | Recruiting | Düsseldorf | 40215 | Germany |
|
| Klinikum Forchheim | Recruiting | Forchheim | Germany |
|
| Universitätsklinikum Freiburg- Abt. Innere Medizin II | Recruiting | Freiburg im Breisgau | Germany |
|
| Marienhospital Gelsenkirchen | Recruiting | Gelsenkirchen | Germany |
|
| Universitätsmedizin Göttingen | Recruiting | Göttingen | Germany |
|
| Krankenhaus Emmaus-Niesky | Recruiting | Niesky | Germany |
|
| Elisabeth Klinikum Schmalkalde | Recruiting | Schmalkalden | Germany |
|
| Petrus Krankenhaus Wuppertal | Recruiting | Wuppertal | Germany |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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