NCT02731859

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

5 years

First QC Date

January 27, 2016

Last Update Submit

June 22, 2017

Conditions

ObesityDiabetes Mellitus

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (32)

  • 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

  • +27 more secondary outcomes

Study Arms (1)

EndoBarrier

All patients with EndoBarrier treatment

Device: Insertion of EndoBarrier for approximately one year

Interventions

Insertion of EndoBarrier for approximately one yearDEVICE

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

EndoBarrier

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Klinikum Augsburg

Augsburg, Germany

RECRUITING

Evangelisches Krankenhaus Köln-Weyertal

Cologne, Germany

RECRUITING

Donau-Ries Klinik Donauwörth

Donauwörth, Germany

RECRUITING

St. Martinus Krankenhaus Düsseldorf

Düsseldorf, 40215, Germany

RECRUITING

Klinikum Forchheim

Forchheim, Germany

RECRUITING

Universitätsklinikum Freiburg- Abt. Innere Medizin II

Freiburg im Breisgau, Germany

RECRUITING

Marienhospital Gelsenkirchen

Gelsenkirchen, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, Germany

RECRUITING

Krankenhaus Emmaus-Niesky

Niesky, Germany

RECRUITING

Elisabeth Klinikum Schmalkalde

Schmalkalden, Germany

RECRUITING

Petrus Krankenhaus Wuppertal

Wuppertal, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29504053DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Jens Aberle

    University hospital Hamburg, Endokrinology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Hinz

CONTACT

040/741020901ni.sauer@uke.de

Nina Sauer

CONTACT

01781642802ninasauer@ymail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

April 8, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(11)