Spatz Adjustable Balloon for Obesity (SABO)

Inclusion Criteria

• Age 22 - 65
• BMI ≥ 30 and 2cm or severe or intractable gastro-esophageal reflux symptoms.
• Acid reflux symptoms to any degree that require more than one medication for symptom control.
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
• Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
• Severe coagulopathy.
• Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
• Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Chronic abdominal pain
• Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
• Hepatic insufficiency or cirrhosis
• Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months.
• Alcoholism or drug addiction.
• Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
• Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
• Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
• Patients who have ever developed a serotonin syndrome and are currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device.
• Patients who are pregnant or breast-feeding.
• Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly-controlled hypertension, required use of NSAIDs
• Subjects who have tested positive for H. Pylori.
• Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
• Subjects who are taking corticosteroids, immunosuppressants, and narcotics
• Subjects who are taking diet pills
• Use of an intragastric device prior to this study due to the potential increase in risk associated with implantation of a balloon in a previously instrumented and possibly scarred stomach.
• Participation in any clinical study which could affect weight loss within the past 6 months due to the potential to confound findings.
• Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
• Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
• Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator because of an increased risk profile.
• Specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or Prader Willi syndrome
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
• Known history of endocrine disorders affecting weight