Pilot Study to Evaluate A Novel Gastric Space Occupying Device

Exclusion Criteria

• •1. 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;
• •2. 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;
• •3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
• •4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
• •5. History or symptoms of thyroid disease which is not controlled by medication;
• •6. Have severe renal, hepatic, pulmonary disease or cancer;
• •7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
• •8. Have a history of adhesive peritonitis;
• •9. History or symptoms of esophageal and/or gastric varices;
• •10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
• •11. History or symptoms of inflammatory bowel disease, such as Chron's disease;
• •12. History of/ signs and /or symptoms of duodenal or gastric ulcer;
• •13. Have gastroparesis;
• •14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
• •15. Currently using pharmaceutical agents for weight loss;