NCT01114438

Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Morphic Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.

Detailed description

Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' EndoBarrier represents a viable alternative to other short-term pre-surgical weight loss methods. EndoBarrier is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality

Conditions

• Type 2 Diabetes
• Obesity

Interventions

Type	Name	Description
DEVICE	EndoBarrier Gastrointestinal Liner	EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-01-01
• Completion: 2013-07-01
• First posted: 2010-05-03
• Last updated: 2017-04-24
• Results posted: 2017-02-20

Locations

3 sites across 1 country: United Kingdom