Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)

Exclusion Criteria

• •1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
• •2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
• •3. Prior open or laparoscopic bariatric surgery.
• •4. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
• •5. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
• •6. 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.
• •7. A gastric mass or gastric polyps \> 1 cm in size.
• •8. A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
• •9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
• •10. Achalasia or any other severe esophageal motility disorder
• •11. Severe coagulopathy.
• •12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C \>= 9.
• •13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• •14. Chronic abdominal pain
• •15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
• •16. Hepatic insufficiency or cirrhosis
• •17. Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
• •18. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
• •19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
• •20. Patients receiving daily prescribed treatment with high dose aspirin (\> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
• •21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
• •22. Patients who are pregnant or breast-feeding.
• •23. 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
• •24. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
• •25. Subjects who are taking corticosteroids, immunosuppressants, and narcotics
• •26. Subjects who are taking diet pills
• •27. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
• •28. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
• •29. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
• •30. Specific diagnosed genetic disorder such as Prader Willi syndrome.
• •31. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
• •32. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.