REvision of VSG with Ablation of the Mucosa Procedure

Inclusion Criteria:

1. Male and female patients who have:

2. BMI of 30 kg/m2 or greater, AND

3. regained at least 25% of the total weight lost after initial successfulresponse to sleeve gastrectomy. defined as Excess Weight Loss (EWL) greaterthan 50% or Total Body Weight Loss (TBWL) exceeding 20%

4. Must have undergone SG at least three years before the time of enrollment

5. Age range: 22 - 60 years

6. Must agree to refrain from using weight loss medications such as Meridia, Saxenda,Januvia, Xenical, Duromine, GLP-1 agonists (e.g., Ozempic, Wegovy) and dualGLP-1/GIP agonists (e.g., Mounjaro, Zepbound), as well as any over-the-counterweight loss medications or supplements throughout the study.

7. Women of childbearing potential (WOCBP) must agree to use acceptable contraceptionmethods.

8. Must agree not to donate blood during participation in the study.

9. Should be able to comply with study requirements, understand, and sign the InformedConsent Form.

10. Stable weight defined as a fluctuation of less than 5% for at least 3 months priorto the screening visit.

11. Should have a history of failure to lose weight using conventional diet andlifestyle therapies.

12. Must have reliable access to wifi and/or internet services.

13. Must express willingness to comply with the substantial lifelong dietaryrestrictions required by the 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 asrequired 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 fortreatment 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 ofsulfonylurea (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 adequatelyreplaced, including but not limited to celiac disease, or pre-existing symptoms ofsystemic lupus erythematosus, scleroderma or other autoimmune connective tissuedisorder.

12. Previous endoscopic bariatric procedures or conditions, prior intra-gastric balloonor another gastric implant.

13. History of diabetic gastroparesis.

14. Known active hepatitis or active liver disease other than Non-Alcoholic Fatty LiverDisease or Non-Alcoholic Steatohepatitis.

15. Acute gastrointestinal illness in the previous 7 days.

16. Known history of irritable bowel syndrome, radiation enteritis, or otherinflammatory bowel disease, such as Crohn's disease.

17. Known history of a structural or functional disorder of the esophagus that mayimpede passage of the device through the gastrointestinal tract or increase the riskof 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 theesophagus.

18. Known history of a structural or functional disorder of the esophagus, including anyswallowing disorder, esophageal chest pain disorders, or drug-refractory esophagealreflux symptoms.

19. Known history of a structural or functional disorder of the stomach, includinggastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (>3cm), cancer, or any other disorder of the stomach.

20. Known history of chronic symptoms suggestive of a structural or functional disorderof the stomach, including any symptoms of chronic upper abdominal pain, chronicnausea, chronic vomiting, chronic dyspepsia, or symptoms suggestive ofgastroparesis, including post-prandial fullness or pain, post-prandial nausea orvomiting, 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 thescreening process if they are treated with an appropriate antibiotic regimen, anderadication 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 4weeks post procedure.

26. Use of systemic glucocorticoids (excluding topical or ophthalmic application orinhaled forms) for more than 10 consecutive days within 90 days prior to theScreening 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 lossmedications at screening.

29. Untreated/inadequately treated hypothyroidism, defined as an elevatedThyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormonereplacement therapy, must be on a stable dose for at least 6 weeks prior toScreening.

30. Persistent Anemia, defined as Hemoglobin <10 g/dL.

31. Significant cardiovascular disease including a known history of valvular disease, ormyocardial infarction, heart failure, transient ischemic attack, or stroke withinthe last 6 months.

32. Known moderate or severe chronic kidney disease (CKD), with estimated glomerularfiltration rate (eGFR) <45 ml/min/1.73m2 (estimated by MDRD).

33. Known immunocompromised status, including but not limited to individuals who haveundergone organ transplantation, chemotherapy, or radiotherapy within the past 12months, who have clinically significant leukopenia, who are positive for the humanimmunodeficiency virus (HIV) or whose immune status makes the subject a poorcandidate 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 basalcell or treated squamous cell carcinoma).

36. Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type

38. Not a candidate for surgery or general anesthesia.

39. Active illicit substance abuse or alcoholism.

40. Current smoker or smoking history in the last six months.

41. Participating in another ongoing clinical trial of an investigational drug ordevice.

42. Any other mental or physical condition which, in the opinion of the Investigator,makes the subject a poor candidate for clinical trial participation.

43. Other medical conditions that do not allow for an endoscopic procedure.