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

EndoBarrier Register Deutschland

Sponsors

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Collaborator: GI Dynamics

Source 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.

Overall Status Unknown status
Start Date January 2014
Completion Date January 2019
Primary Completion Date January 2019
Study Type Observational [Patient Registry]
Primary Outcome
Measure 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
Measure Time Frame
Number of participants with treatment-related adverse events From Implantation to at least 2 years follow up
Improvement of subjective Arthropathia 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 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
Enrollment 1000
Condition
Intervention

Intervention Type: Device

Intervention Name: Insertion of EndoBarrier for approximately one year

Description: Insertion of EndoBarrier for approximately one year then explantation and follow-up

Arm Group Label: EndoBarrier

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- clinical decision for treatment with EndoBarrier

- informed consent for registry participation

Exclusion Criteria:

- Patients not meeting the inclusion criteria

- age < 18

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jens Aberle Principal Investigator University hospital Hamburg, Endokrinology
Overall Contact

Last Name: Julia Hinz

Phone: 040/741020901

Email: [email protected]

Location
Facility: Status: Contact:
Klinikum Augsburg | Augsburg, Germany Recruiting Heinle
Donau-Ries Klinik Donauwörth | Donauwörth, Germany Recruiting Eberl
St. Martinus Krankenhaus Düsseldorf | Düsseldorf, 40215, Germany Recruiting Gijbels
Klinikum Forchheim | Forchheim, Germany Recruiting Dewald
Universitätsklinikum Freiburg- Abt. Innere Medizin II | Freiburg, Germany Recruiting Dr. Laubner/Prof. Seufert
Marienhospital Gelsenkirchen | Gelsenkirchen, Germany Recruiting Dederichs
Universitätsmedizin Göttingen | Göttingen, Germany Recruiting Raddatz
Evangelisches Krankenhaus Köln-Weyertal | Köln, Germany Recruiting Loeff
Krankenhaus Emmaus-Niesky | Niesky, Germany Recruiting Stengel
Elisabeth Klinikum Schmalkalde | Schmalkalden, Germany Recruiting Jung
Petrus Krankenhaus Wuppertal | Wuppertal, Germany Recruiting Göbel
Location Countries

Germany

Verification Date

June 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Arm Group

Label: EndoBarrier

Description: All patients with EndoBarrier treatment

Acronym EBRD
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov