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

Universitätsklinikum Hamburg-Eppendorf

Status: Unknown

Conditions: Diabetes Mellitus; Obesity

Treatments: Device: Insertion of EndoBarrier for approximately one year

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02731859

EBRD 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients not meeting the inclusion criteria
• age < 18

Trial design

1,000 participants in 1 patient group

EndoBarrier

Description:

All patients with EndoBarrier treatment

Treatment:

Device: Insertion of EndoBarrier for approximately one year