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

Obesity Clinical Trial

— EBRD  

Official title:

EndoBarrier Register Deutschland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02731859
• Other study ID #: EBRD 001
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2016
• Last updated: June 22, 2017
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: June 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Julia Hinz
• Phone: 040/741020901
• Email: ni.sauer[@]uke.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical decision for treatment with EndoBarrier

• informed consent for registry participation

Exclusion Criteria:

• Patients not meeting the inclusion criteria

• age < 18

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Augsburg	Augsburg
Germany	Donau-Ries Klinik Donauwörth	Donauwörth
Germany	St. Martinus Krankenhaus Düsseldorf	Düsseldorf
Germany	Klinikum Forchheim	Forchheim
Germany	Universitätsklinikum Freiburg- Abt. Innere Medizin II	Freiburg
Germany	Marienhospital Gelsenkirchen	Gelsenkirchen
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Evangelisches Krankenhaus Köln-Weyertal	Köln
Germany	Krankenhaus Emmaus-Niesky	Niesky
Germany	Elisabeth Klinikum Schmalkalde	Schmalkalden
Germany	Petrus Krankenhaus Wuppertal	Wuppertal

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	GI Dynamics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of HbA1C		From Implantation to at least 2 years follow up
Primary	Reduction of Antidiabetic Medication		From Implantation to at least 2 years follow up
Primary	Excess weight loss		From Implantation to at least 2 years follow up
Primary	Reduction of BMI		From Implantation to at least 2 years follow up
Primary	Weight reduction		From Implantation to at least 2 years follow up
Secondary	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
Secondary	Improvement of subjective Arthropathia	Qualitative Measurement of improvement of subjective Arthropathia, no scale is used	From Implantation to at least 2 years follow up
Secondary	Smoking Status		From Implantation to at least 2 years follow up
Secondary	Time of implantation and explantation		From Implantation to at least 2 years follow up
Secondary	Reduction of fasting glucose		From Implantation to at least 2 years follow up
Secondary	Reduction of fasting insulin		From Implantation to at least 2 years follow up
Secondary	Reduction of fasting C-Peptide		From Implantation to at least 2 years follow up
Secondary	Reduction of systolic blood pressure		From Implantation to at least 2 years follow up
Secondary	Reduction of diastolic blood pressure		From Implantation to at least 2 years follow up
Secondary	Reduction of antihypertensive medication		From Implantation to at least 2 years follow up
Secondary	Reduction of total cholesterol		From Implantation to at least 2 years follow up
Secondary	Reduction of LDL-cholesterol		From Implantation to at least 2 years follow up
Secondary	Increase of HDL-cholesterol		From Implantation to at least 2 years follow up
Secondary	Reduction of fasting triglycerides		From Implantation to at least 2 years follow up
Secondary	Reduction of antihyperlipidemic medication		From Implantation to at least 2 years follow up
Secondary	Reduction of 25OHD3		From Implantation to at least 2 years follow up
Secondary	Reduction of Calcium		From Implantation to at least 2 years follow up
Secondary	Reduction of Ferritin	Ferritin will be measured	From Implantation to at least 2 years follow up
Secondary	Reduction of Hemoglobin		From Implantation to at least 2 years follow up
Secondary	Reduction of Vitamin B12		From Implantation to at least 2 years follow up
Secondary	Reduction of Albumin		From Implantation to at least 2 years follow up
Secondary	Reduction of Folic acid		From Implantation to at least 2 years follow up
Secondary	Reduction of Vitamin B1		From Implantation to at least 2 years follow up
Secondary	Reduction of Vitamin B6		From Implantation to at least 2 years follow up
Secondary	Reduction of CK		From Implantation to at least 2 years follow up
Secondary	Reduction of AST		From Implantation to at least 2 years follow up
Secondary	Reduction of ALT		From Implantation to at least 2 years follow up
Secondary	Reduction of hsCRP		From Implantation to at least 2 years follow up
Secondary	Duration of implantation process of the EndoBarrier in minutes		From Implantation to at least 2 years follow up
Secondary	Duration of ithe explantation process of the EndoBarrier in minutes		From Implantation to at least 2 years follow up
Secondary	Reduction of waist circumference		From Implantation to at least 2 years follow up
Secondary	Reduction of daily caloric intake		From Implantation to at least 2 years follow up