Pilot Study to Evaluate A Novel Gastric Space Occupying Device

Inclusion criteria

• Age between 21-64 years
• BMI 27-40 Kg/m2
• No history of weight reduction of more than 5% of total body weight in the past 6 months

Exclusion criteria

• Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
• Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
• Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
• Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
• History or symptoms of thyroid disease which is not controlled by medication;
• Have severe renal, hepatic, pulmonary disease or cancer;
• Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
• Have a history of adhesive peritonitis;
• History or symptoms of esophageal and/or gastric varices;
• Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
• History or symptoms of inflammatory bowel disease, such as Chron's disease;
• History of/ signs and /or symptoms of duodenal or gastric ulcer;
• Have gastroparesis;
• Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
• Currently using pharmaceutical agents for weight loss;