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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Insertion of EndoBarrier for approximately one year then explantation and follow-up
Klinikum Augsburg
Augsburg, Germany
RECRUITINGEvangelisches Krankenhaus Köln-Weyertal
Cologne, Germany
RECRUITINGReduction of HbA1C
Time frame: From Implantation to at least 2 years follow up
Reduction of Antidiabetic Medication
Time frame: From Implantation to at least 2 years follow up
Excess weight loss
Time frame: From Implantation to at least 2 years follow up
Reduction of BMI
Time frame: From Implantation to at least 2 years follow up
Weight reduction
Time frame: From Implantation to at least 2 years follow up
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
Time frame: From Implantation to at least 2 years follow up
Improvement of subjective Arthropathia
Qualitative Measurement of improvement of subjective Arthropathia, no scale is used
Time frame: From Implantation to at least 2 years follow up
Smoking Status
Time frame: From Implantation to at least 2 years follow up
Time of implantation and explantation
Time frame: From Implantation to at least 2 years follow up
Reduction of fasting glucose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Donau-Ries Klinik Donauwörth
Donauwörth, Germany
St. Martinus Krankenhaus Düsseldorf
Düsseldorf, Germany
RECRUITINGKlinikum Forchheim
Forchheim, Germany
RECRUITINGUniversitätsklinikum Freiburg- Abt. Innere Medizin II
Freiburg im Breisgau, Germany
RECRUITINGMarienhospital Gelsenkirchen
Gelsenkirchen, Germany
RECRUITINGUniversitätsmedizin Göttingen
Göttingen, Germany
RECRUITINGKrankenhaus Emmaus-Niesky
Niesky, Germany
RECRUITINGElisabeth Klinikum Schmalkalde
Schmalkalden, Germany
RECRUITING...and 1 more locations
Time frame: From Implantation to at least 2 years follow up
Reduction of fasting insulin
Time frame: From Implantation to at least 2 years follow up
Reduction of fasting C-Peptide
Time frame: From Implantation to at least 2 years follow up
Reduction of systolic blood pressure
Time frame: From Implantation to at least 2 years follow up
Reduction of diastolic blood pressure
Time frame: From Implantation to at least 2 years follow up
Reduction of antihypertensive medication
Time frame: From Implantation to at least 2 years follow up
Reduction of total cholesterol
Time frame: From Implantation to at least 2 years follow up
Reduction of LDL-cholesterol
Time frame: From Implantation to at least 2 years follow up
Increase of HDL-cholesterol
Time frame: From Implantation to at least 2 years follow up
Reduction of fasting triglycerides
Time frame: From Implantation to at least 2 years follow up
Reduction of antihyperlipidemic medication
Time frame: From Implantation to at least 2 years follow up
Reduction of 25OHD3
Time frame: From Implantation to at least 2 years follow up
Reduction of Calcium
Time frame: From Implantation to at least 2 years follow up
Reduction of Ferritin
Ferritin will be measured
Time frame: From Implantation to at least 2 years follow up
Reduction of Hemoglobin
Time frame: From Implantation to at least 2 years follow up
Reduction of Vitamin B12
Time frame: From Implantation to at least 2 years follow up
Reduction of Albumin
Time frame: From Implantation to at least 2 years follow up
Reduction of Folic acid
Time frame: From Implantation to at least 2 years follow up
Reduction of Vitamin B1
Time frame: From Implantation to at least 2 years follow up
Reduction of Vitamin B6
Time frame: From Implantation to at least 2 years follow up
Reduction of CK
Time frame: From Implantation to at least 2 years follow up
Reduction of AST
Time frame: From Implantation to at least 2 years follow up
Reduction of ALT
Time frame: From Implantation to at least 2 years follow up
Reduction of hsCRP
Time frame: From Implantation to at least 2 years follow up
Duration of implantation process of the EndoBarrier in minutes
Time frame: From Implantation to at least 2 years follow up
Duration of ithe explantation process of the EndoBarrier in minutes
Time frame: From Implantation to at least 2 years follow up
Reduction of waist circumference
Time frame: From Implantation to at least 2 years follow up
Reduction of daily caloric intake
Time frame: From Implantation to at least 2 years follow up