Endoscopic gastric mucosal ablation for weight regain after sleeve gastrectomy

REvision of VSG with Ablation of the Mucosa Procedure

This study is testing a new procedure to help people who have gained weight after gastric sleeve surgery lose weight again by using a special technique to treat the stomach lining.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 22 Years to 60 Years
• Sex: All
• Sponsor: True You Weight Loss (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Cary, North Carolina)
• Trial ID: NCT06671119 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation in patients who have regained weight after sleeve gastrectomy. The procedure aims to ablate the gastric mucosa of the pseudo greater curvature created after the initial surgery. By targeting the mucosal layer, the study hypothesizes that GMA can effectively aid in weight loss and improve metabolic outcomes. Participants will undergo this minimally invasive procedure in a single endoscopic session, with the goal of addressing obesity-related health issues.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 60 with a BMI of 30 or greater who have regained at least 25% of their weight lost after sleeve gastrectomy.

Not a fit: Patients who have not undergone sleeve gastrectomy or those who are not experiencing weight regain may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could provide a new option for patients struggling with weight regain after sleeve gastrectomy, potentially leading to significant weight loss and improved metabolic health.

How similar studies have performed: Previous studies have shown positive outcomes with similar endoscopic interventions for weight regain, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Male and female patients who have:

   1. BMI of 30 kg/m2 or greater, AND
   2. regained at least 25% of the total weight lost after initial successful response to sleeve gastrectomy. defined as Excess Weight Loss (EWL) greater than 50% or Total Body Weight Loss (TBWL) exceeding 20%
2. Must have undergone SG at least three years before the time of enrollment
3. Age range: 22 - 60 years
4. Must agree to refrain from using weight loss medications such as Meridia, Saxenda, Januvia, Xenical, Duromine, GLP-1 agonists (e.g., Ozempic, Wegovy) and dual GLP-1/GIP agonists (e.g., Mounjaro, Zepbound), as well as any over-the-counter weight loss medications or supplements throughout the study.
5. Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
6. Must agree not to donate blood during participation in the study.
7. Should be able to comply with study requirements, understand, and sign the Informed Consent Form.
8. Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to the screening visit.
9. Should have a history of failure to lose weight using conventional diet and lifestyle therapies.
10. Must have reliable access to wifi and/or internet services.
11. Must express willingness to comply with the substantial lifelong dietary restrictions 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 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.

Where this trial is running

Cary, North Carolina

• True You Weight Loss — Cary, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Christopher McGowan, MD, MSCR — True You Weight Loss
• Study coordinator: Shannon Casey, MS

Conditions Obesity and Obesity-related Medical Conditions; Obesity and Overweight; Obesity Prevention; Obesity Recidivism; obesity; obesity and overweight; endoscopic bariatric therapy; ablation