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

EndoBarrier Register Deutschland

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Diabetes Mellitus
• Intervention / Treatment: Device: Insertion of EndoBarrier for approximately one year

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Julia Hinz; Phone Number: 040/741020901; Email: ni.sauer@uke.de
• Study Contact Backup: Name: Nina Sauer; Phone Number: 01781642802; Email: ninasauer@ymail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with either Obesity and/or Diabetes mellitus who are treated with the EndoBarrier

Description

Inclusion Criteria:

• clinical decision for treatment with EndoBarrier
• informed consent for registry participation

Exclusion Criteria:

• Patients not meeting the inclusion criteria
• age < 18

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EndoBarrier; All patients with EndoBarrier treatment	Device: Insertion of EndoBarrier for approximately one year; Insertion of EndoBarrier for approximately one year then explantation and follow-up

What is the study measuring?

Primary Outcome Measures

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 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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: GI Dynamics
• Investigators: Principal Investigator: Jens Aberle, University hospital Hamburg, Endokrinology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: April 2, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: EBRD 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO