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

June 22, 2017 updated by: Universitätsklinikum Hamburg-Eppendorf

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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
        • Universitätsmedizin Göttingen
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Reduction of HbA1C
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of Antidiabetic Medication
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Excess weight loss
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of BMI
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Weight reduction
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: From Implantation to at least 2 years follow up
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
Time Frame: From Implantation to at least 2 years follow up
Qualitative Measurement of improvement of subjective Arthropathia, no scale is used
From Implantation to at least 2 years follow up
Smoking Status
Time Frame: From Implantation to at least 2 years follow up
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
From Implantation to at least 2 years follow up
Reduction of fasting glucose
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of fasting insulin
Time Frame: From Implantation to at least 2 years follow up
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
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
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
From Implantation to at least 2 years follow up
Reduction of antihypertensive medication
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of total cholesterol
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of LDL-cholesterol
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Increase of HDL-cholesterol
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of fasting triglycerides
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of antihyperlipidemic medication
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of 25OHD3
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of Calcium
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of Ferritin
Time Frame: From Implantation to at least 2 years follow up
Ferritin will be measured
From Implantation to at least 2 years follow up
Reduction of Hemoglobin
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of Vitamin B12
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of Albumin
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of Folic acid
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of Vitamin B1
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of Vitamin B6
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of CK
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of AST
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of ALT
Time Frame: From Implantation to at least 2 years follow up
From Implantation to at least 2 years follow up
Reduction of hsCRP
Time Frame: From Implantation to at least 2 years follow up
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
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
From Implantation to at least 2 years follow up
Reduction of waist circumference
Time Frame: From Implantation to at least 2 years follow up
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
From Implantation to at least 2 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GI Dynamics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jens Aberle, University hospital Hamburg, Endokrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EBRD 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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