A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects

Exclusion Criteria

• •1. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions
• •2. Prior open or laparoscopic bariatric surgery.
• •3. Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
• •4. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
• •5. A gastric mass.
• •6. A hiatal hernia \> 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
• •7. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
• •8. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
• •9. Severe coagulopathy
• •10. Hepatic insufficiency or cirrhosis
• •11. 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 6 months.
• •12. Alcoholism or drug addiction.
• •13. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
• •14. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
• •15. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
• •16. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
• •17. 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.
• •18. Patients who are pregnant or breast-feeding.
• •19. Significant endoscopic abnormalities immediately prior to device insertion.