Abiliti™ Treatment in Obese Subjects

Exclusion Criteria

• •Any prior bariatric surgery
• •Other implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator)
• •Diagnosed with past or current psychiatric condition that may impair his/her ability to comply with the study procedures
• •Use of anti-psychotic medications
• •Diagnosed with a eating disorder such as bulimia or binge eating
• •Obesity due to an endocrinopathy (e.g. Cushing disease)
• •Insulin therapy
• •GI disease such as hiatal hernia (\>5cm), gastroparesis, esophageal motility disorders or intractable constipation.
• •Cirrhosis, chronic pancreatitis
• •History of intestinal obstruction or adhesive peritonitis
• •Any history of peptic ulcer disease within 5 years prior to enrollment
• •Women who are pregnant, lactating or anticipate becoming pregnant within 24 months
• •Arthritis or other pathologies limiting physical activities that physician feels should exclude the patient from the study.
• •Chronic use of aspirin and/or non steroidal anti-inflammatory medications and unwillingness to discontinue use
• •Cardiac history that physician feels should exclude the patient from the study.
• •Concurrent use of weight loss medications.
• •Use of another investigational device or agent in the 30 days prior to enrollment
• •A history of life-threatening disease within 5 years prior to enrollment
• •Any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study