NCT02731859

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

EndoBarrier Register Deutschland

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Obesity
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Insertion of EndoBarrier for approximately one year	Insertion of EndoBarrier for approximately one year then explantation and follow-up

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-04-08
• Last updated: 2017-06-23

Locations

11 sites across 1 country: Germany