The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.
Patients with obesity are at significantly greater risk of developing significant co-morbid complications, and are associated with an increased risk in all-cause mortality. The GI Endobarrier Liner represents a viable alternative to other short-term weight loss methods. It is a minimally invasive endoscopic procedure, which may allow patients to recover faster with less morbidity and mortality. This study is investigating the safety and efficacy of the GI Endobarrier Liner in patients who are candidates for bariatric surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Medical device placed endoscopically in the duodenum
Dr. Nicholas Quezada
Santiago, Chile
Assessment of % Excess Weight Loss
Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as \[(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)\] \* 100).
Time frame: 12 months
Improvement in Type 2 Diabetic Status
Subjects who achieved HbA1c reduction of 0.5%
Time frame: 12 months
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