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

NCT ID: NCT02731859

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EndoBarrier

All patients with EndoBarrier treatment

Insertion of EndoBarrier for approximately one year

Intervention Type DEVICE

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

Interventions

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Insertion of EndoBarrier for approximately one year

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

* age \< 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Morphic Medical Inc.

INDUSTRY

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Aberle

Role: PRINCIPAL_INVESTIGATOR

University hospital Hamburg, Endokrinology

Locations

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Klinikum Augsburg

Augsburg, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Köln-Weyertal

Cologne, , Germany

Site Status RECRUITING

Donau-Ries Klinik Donauwörth

Donauwörth, , Germany

Site Status RECRUITING

St. Martinus Krankenhaus Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Klinikum Forchheim

Forchheim, , Germany

Site Status RECRUITING

Universitätsklinikum Freiburg- Abt. Innere Medizin II

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Marienhospital Gelsenkirchen

Gelsenkirchen, , Germany

Site Status RECRUITING

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status RECRUITING

Krankenhaus Emmaus-Niesky

Niesky, , Germany

Site Status RECRUITING

Elisabeth Klinikum Schmalkalde

Schmalkalden, , Germany

Site Status RECRUITING

Petrus Krankenhaus Wuppertal

Wuppertal, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Julia Hinz

Role: CONTACT

[email protected]
040/741020901

Nina Sauer

Role: CONTACT

[email protected]
01781642802

Facility Contacts

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Heinle

Role: primary

Loeff

Role: primary

Eberl

Role: primary

Gijbels

Role: primary

Dewald

Role: primary

Dr. Laubner/Prof. Seufert

Role: primary

Dederichs

Role: primary

Raddatz

Role: primary

Stengel

Role: primary

Jung

Role: primary

Göbel

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29504053 (View on PubMed)

Other Identifiers

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EBRD 001

Identifier Type: -

Identifier Source: org_study_id

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