• Have a BMI ≥ 27;

• Be male or female, between 18 and 65 years of age, inclusive;

• Have a history of excess weight (BMI ≥ 27 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;

• Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;

• Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 52 weeks);

• Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing, and must be willing to take prescribed proton pump inhibitors (PPIs);

• Be able to provide written informed consent;

• Have successful completion of the pre-placement screening and educational programs supporting that the subject is an appropriate study candidate;

• Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.