Obalon Balloon System Pivotal IDE (SMART) Trial

Exclusion Criteria

• •1. Significant weight loss in the past 12 months
• •2. Use of medications or other substances known to induce weight gain or weight loss
• •3. Participation in any clinical study at the start of this trial or in the last year
• •4. Known history of endocrine disorders affecting weight
• •5. Currently receiving chronic steroid or immunosuppressive therapy or has previously been diagnosed with HIV
• •6. Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders
• •7. Intent to undergo gastric surgery or gastric banding during the study period or within the 6 month period after completion of this study
• •8. Prior use of any weight loss medical device
• •9. Known history of structural or functional disorders of the esophagus
• •10. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
• •11. Known history of structural or functional disorders of the stomach
• •12. Known history of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety
• •13. Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal (GI) tract
• •14. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
• •15. Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
• •16. Known history of GI surgeries that may have resulted in anatomical GI tract abnormalities
• •17. Type 1 diabetes
• •18. Type 2 diabetes requiring insulin or other hypoglycemic oral agents.
• •19. Experienced a myocardial infarction, has a known history of angina, a known history of congestive heart failure, or is currently being medically treated for any other cardiac condition
• •20. Poorly controlled hypertension, (≥ 160 mmHg Systolic and ≥ 100mmHg Diastolic).
• •21. End stage renal disease or requiring hemodialysis within the past 6 months
• •22. Unwilling or unable to avoid Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Aspirin, Diclofenac, Ibuprofen, Naproxen, or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study period
• •23. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying
• •24. Subjects requiring the use of anti-platelet drugs or other agents affecting the normal clotting of blood
• •25. Untreated or unstable alcohol or illicit drug addiction
• •26. Known history of allergies to any component of the device materials
• •27. Currently pregnant or breastfeeding or intention of becoming pregnant during the study
• •28. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
• •29. Subject is employed by the investigator, or is a close relative of the investigator, or the investigator's staff
• •30. Subject is a close relative of another subject already enrolled in the study.
• •31. Any other condition that, in the opinion of the investigator, would interfere with subject participation, may confound the study results, or interfere with compliance with the study (e.g., psychosocial issues).