Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Validation Study

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 severe (LA Grade C or D) esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammatory disease such as Crohn's disease or celiac 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. Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes.
• •8. A gastric mass or gastric polyps \> 1 cm in size.
• •9. A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
• •10. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
• •11. Achalasia or any other severe esophageal motility disorder
• •12. Severe coagulopathy.
• •13. 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.
• •14. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
• •15. Chronic abdominal pain.
• •16. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
• •17. Hepatic insufficiency or cirrhosis.
• •18. Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
• •19. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
• •20. Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.
• •21. Patients receiving daily prescribed treatment with high dose aspirin (\> 81mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants.
• •22. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication.
• •23. Patients who are pregnant or breast-feeding.
• •24. Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
• •25. 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.
• •26. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
• •27. Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
• •28. Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease.
• •29. Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer.
• •30. Diagnosis of autoimmune connective tissue disorder (e.g. Systemic lupus erythematosus, scleroderma) or immunocompromised.
• •31. Specific diagnosed genetic disorder such as Prader Willi syndrome.
• •32. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
• •33. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
• •34. At the discretion of the PI for subject safety
• •35. If minority inclusion population target of 10% has not been reached by the 90% enrollment mark (example 43 of 48 subjects), the remaining enrollments will be reserved for minority subjects (example 5 of 48 subjects).