REvision of VSG with Ablation of the Mucosa Procedure

Exclusion Criteria

• •1. Inadequate response to sleeve gastrectomy
• •2. Patients requiring exogenous insulin.
• •3. HbA1c \> 8.5%
• •4. Pregnant or breast-feeding or intending to get pregnant during the study.
• •5. Unwilling or unable to complete the Visual Analogue Scale for pain assessment, patient questionnaires, or comply with study visits and other study procedures as required per protocol.
• •6. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• •7. Previous use of any types of insulin for \> 1 month (at any time, except for treatment of gestational diabetes).
• •8. Change in diabetic treatment within the last three months.
• •9. Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of sulfonylurea (SU), biguanides and sodium-dependent glucose co-transporter 2 (SGLT-2) inhibitors.
• •10. GLP-1 use in the preceding 6 months.
• •11. Known autoimmune disease, other than autoimmune thyroid disease, which is adequately replaced, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
• •12. Previous endoscopic bariatric procedures or conditions, prior intra-gastric balloon or another gastric implant.
• •13. History of diabetic gastroparesis.
• •14. Known active hepatitis or active liver disease other than Non-Alcoholic Fatty Liver Disease or Non-Alcoholic Steatohepatitis.
• •15. Acute gastrointestinal illness in the previous 7 days.
• •16. Known history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel disease, such as Crohn's disease.
• •17. Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase the risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus.
• •18. Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug-refractory esophageal reflux symptoms.
• •19. Known history of a structural or functional disorder of the stomach, including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (\>3 cm), cancer, or any other disorder of the stomach.
• •20. Known history of chronic symptoms suggestive 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.
• •21. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea, or vomiting.
• •22. Active H. pylori infection (Subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen, and eradication has been confirmed).
• •23. History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia.
• •24. Current use of anticoagulation therapy.
• •25. Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks post procedure.
• •26. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
• •27. Use of drugs known to affect GI motility (e.g., Metoclopramide).
• •28. Receiving any weight loss medications such as Meridia, Xenical, Saxenda, Januvia, Duromine, GLP-1 agonists, GIP/GLP-1 dual agonists, or over-the-counter weight loss medications at screening.
• •29. Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on a stable dose for at least 6 weeks prior to Screening.
• •30. Persistent Anemia, defined as Hemoglobin \<10 g/dL.
• •31. Significant cardiovascular disease including a known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within the last 6 months.
• •32. Known moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m2 (estimated by MDRD).
• •33. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.
• •34. Active systemic infection.
• •35. Known active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma).
• •36. Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type 1.
• •37. Not a candidate for surgery or general anesthesia.
• •38. Active illicit substance abuse or alcoholism.
• •39. Current smoker or smoking history in the last six months.
• •40. Participating in another ongoing clinical trial of an investigational drug or device.
• •41. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.
• •42. Other medical conditions that do not allow for an endoscopic procedure.