NCT00791128

Study for Pre-Surgical Weight Loss in Type II Diabetes Patients

A Phase II Single-Center, Prospective, Open Label Study of Safety and Efficacy, of the GI Sleeve for Pre-Surgical Weight Loss, in Type II Diabetes Patients (Cohort 06-6B Only)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (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 determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients

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' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve 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	GI Liner	Medical device placed endoscopically in the duodenum, nutritional counseling

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-03-01
• Completion: 2010-12-01
• First posted: 2008-11-14
• Last updated: 2017-06-01
• Results posted: 2016-12-28

Locations

1 site across 1 country: Brazil