ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss

Inclusion criteria

• Male and female subjects between the ages of 22 to 60
• A BMI between 30.0 to 40.0 kg/m2, inclusive. Subjects with a BMI of 30.0 kg/m2 to 34.9 kg/m2 are required to have one or more obesity-related comorbidities
• History of obesity for at least 2 years, with history of failure of medically or commercially supervised weight loss program
• < 5% change in body weight for at least 3 months
• Negative pregnancy test, agree to be on birth control for the duration of participation
• Informed consent
• Willing and able to comply with study procedures

Exclusion criteria

• Pregnancy or nursing
• Hormonal or genetic cause for obesity
• Prior history of any GI surgery or endoscopic intervention
• Chronic use of medications likely to contribute to weight gain or prevent weight loss
• Gastric or duodenal ulcers
• Positive for H. pylori
• History of severe dyspepsia
• GI tract motility disorders
• History of inflammatory disease of GI tract, coeliac disease, pancreatitis, portal hypertension, cirrhosis, and/or varices
• Diabetes treated with insulin
• HbA1c >7.5%
• Uncontrolled thyroid and adrenal gland disease or uncontrolled hypertension
• History of certain cardiac events
• Localized or systemic infection
• Anemia
• History of asthma likely to require systemic steroid therapy
• Autoimmune connective tissue disorders or immunocompromised
• History of malignancy except non-melanoma skin cancer
• Continuous use of ulcerogenic medication
• On anticoagulation or antiplatelet therapy
• Use of weight-loss medication
• In other weight-loss program
• Unable to take proton pump inhibitor
• Abnormal laboratory values or EKG
• Inability to walk at least 0.8 kilometers per day
• Planned surgical procedure that can impact the conduct of the study
• Known allergy to any component materials in the TPSS
• Smoker or user of nicotine product
• Substance abuse
• Severe, uncontrolled psychiatric illness
• Recent inpatient psychiatric treatment
• Moderate depression
• Bulimia nervosa or binge eating disorder
• Participation in another clinical study
• Employee or family member of Sponsor or study staff
• Have any endoscopic exclusion criteria