REvision of VSG with Ablation of the Mucosa Procedure

You may not qualify if:

• Inadequate response to sleeve gastrectomy
• Patients requiring exogenous insulin.
• HbA1c \> 8.5%
• Pregnant or breast-feeding or intending to get pregnant during the study.
• 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.
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• Previous use of any types of insulin for \> 1 month (at any time, except for treatment of gestational diabetes).
• Change in diabetic treatment within the last three months.
• 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.
• GLP-1 use in the preceding 6 months.
• 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.
• Previous endoscopic bariatric procedures or conditions, prior intra-gastric balloon or another gastric implant.
• History of diabetic gastroparesis.
• Known active hepatitis or active liver disease other than Non-Alcoholic Fatty Liver Disease or Non-Alcoholic Steatohepatitis.
• Acute gastrointestinal illness in the previous 7 days.
• +27 more criteria