Obalon Balloon System Pivotal IDE (SMART) Trial

Inclusion criteria

• Male or female between the ages of 22-64 years
• Current BMI of 30.0 - 40 kg/m2
• Previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet
• Willing to attend all protocol-specified follow-up visits plus any additional follow-up visits as required throughout the entire study period
• Willing to avoid non-commercial air travel and scuba diving during the entire study period
• Willing to avoid medications or other substances known to effect weight changes during the study
• Willing to avoid Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or other medications known to be gastric irritants during the study
• Willing to use contraception and avoid pregnancy during the study if the subject is female with child bearing potential
• Willing to provide written informed consent

Exclusion criteria

• Significant weight loss in the past 12 months
• Use of medications or other substances known to induce weight gain or weight loss
• Participation in any clinical study at the start of this trial or in the last year
• Known history of endocrine disorders affecting weight
• Currently receiving chronic steroid or immunosuppressive therapy or has previously been diagnosed with HIV
• Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders
• Intent to undergo gastric surgery or gastric banding during the study period or within the 6 month period after completion of this study
• Prior use of any weight loss medical device
• Known history of structural or functional disorders of the esophagus
• Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
• Known history of structural or functional disorders of the stomach
• 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
• 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
• Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
• Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
• Known history of GI surgeries that may have resulted in anatomical GI tract abnormalities
• Type 1 diabetes
• Type 2 diabetes requiring insulin or other hypoglycemic oral agents.
• 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
• Poorly controlled hypertension, (≥ 160 mmHg Systolic and ≥ 100mmHg Diastolic).
• End stage renal disease or requiring hemodialysis within the past 6 months
• 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
• Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying
• Subjects requiring the use of anti-platelet drugs or other agents affecting the normal clotting of blood
• Untreated or unstable alcohol or illicit drug addiction
• Known history of allergies to any component of the device materials
• Currently pregnant or breastfeeding or intention of becoming pregnant during the study
• Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
• Subject is employed by the investigator, or is a close relative of the investigator, or the investigator's staff
• Subject is a close relative of another subject already enrolled in the study.
• 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).