NCT03072901

Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 244 (actual)
• Sponsor: Morphic Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.

Detailed description

This was a worldwide observational registry of the use of the EndoBarrier for inclusion of subjects treated with the EndoBarrier in centers in Australia, Chile, and the Netherlands. The registry was open to all subjects at participating centers that received the EndoBarrier.

Conditions

• Type 2 Diabetes
• Obesity

Interventions

Type	Name	Description
DEVICE	EndoBarrier Gastrointestinal Liner	The EndoBarrier Gastrointestinal Liner (EndoBarrier) is a nonsurgical metabolic intervention for the treatment of Type 2 diabetes and obesity. By bypassing the duodenum and proximal jejunum, the device may alter signaling pathways that control metabolic processes.1, 2 The effect on patient's glucose levels is immediate as evidenced by meal tolerance testing.3 Since the device also promotes reduced appetite resulting in weight loss, the effect is maintained as the patient loses weight over the implant period. Most patients achieve normal HbA1c and fasting plasma glucose (FPG) levels rapidly within 3-6 months.

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2017-03-07
• Last updated: 2017-03-07

Regulatory

• FDA-regulated device study