Clinical Trials

Inclusion Criteria

• Informed consent
• Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 
• BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more severe obesity related co-morbid conditions
• Female or male
• Age 18-65 years inclusive
• Type 2 diabetes mellitus that is well-controlled
  • At selected centers
  • Limited to approximately 26 subjects
• Failed to respond to a supervised diet/exercise program engaged in for at least 6 months
• Able to complete all study visits and procedures

Exclusion Criteria

• Concurrent chronic pancreatic disease
• History of Crohn's disease and/or ulcerative colitis
• History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery
• History of pulmonary embolism or blood coagulation disorders
• Clinically significant hiatal hernia known from medical record or determined by upper endoscopy prior to implant
• Current portal hypertension and/or esophageal varices
• Intra-operative exclusion for hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at the time of surgery
• Treatment with weight-loss prescription drug therapy within the prior three months, and the use of prescription drug therapy or over-the-counter weight loss preparations for the duration of the trial
• Smoking cessation within the prior six months
• Known genetic cause of obesity
• Overall sustained reduction of more than 10% of body weight in the previous 12 months
• Pre-operative diet with intent to lose weight prior to surgery