Clinical trial NCT06671119: REvision of VSG with Ablation of the Mucosa Procedure
Official title: REvision of VSG with Ablation of the Mucosa Procedure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Obesity-related Medical Conditions
Obesity and Overweight
Obesity Prevention
Obesity Recidivism
Keywords: obesity
obesity and overweight
endoscopic bariatric therapy
ablation
gastric mucosal ablation
GMA
Lead sponsor: True You Weight Loss
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 5
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation after sleeve gastrectomy. In this study, GMA will be performed on patients who have experienced weight regain following an initial successful response to sleeve gastrectomy.

Detailed description: Obesity is a multifaceted chronic disease associated with substantial morbidity and mortality, leading to conditions like diabetes, cardiovascular diseases, and malignancies. Bariatric procedures, such as the sleeve gastrectomy, stand out as the current most effective long-term treatments for obesity. Despite its effectiveness, a significant number of patients experience weight regain during long-term follow-up. Endoscopic minimally invasive bariatric intervention has been proposed as a viable, safe, and effective option for the treatment of weight regain after SG. Gastric mucosal ablation (GMA), in particular, is hypothesized to be a safe and effective endoscopic revisional treatment for weight regain following sleeve gastrectomy based on previous positive pre-clinical and clinical studies. To investigate the feasibility, safety, and tolerability of GMA after sleeve gastrectomy, a single procedure is designed to ablate the gastric mucosa of the pseudo greater curvature created after the sleeve gastrectomy in a single endoscopic session. We hypothesize that endoscopic selective ablation of the gastric mucosa after sleeve gastrectomy is effective as a revisional treatment for weight regain and will result in significant metabolic improvements.

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.

Primary outcomes:
measure: Percent Change in Total Body Weight Loss (TBWL) from Baseline
timeFrame: 6 Months
Secondary outcomes:
measure: Rate of Safety Complications according to Clavien-Dindo Classification
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
measure: Rate of Adverse Events (AE)
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
measure: Post-operative Pain Assessment
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
measure: Percent Change in Total Body Weight Loss (TBWL) from Baseline
timeFrame: Month 12
measure: Quality of Life Assessment
timeFrame: 6 Months
measure: Glucose Homeostasis Assessment
timeFrame: 3 Months, 6 Months
measure: Serum Levels of Lipids Assessment
timeFrame: 3 Months, 6 Months
measure: Gastric Sensory Function Assessment
timeFrame: 3 Months, 6 Months
Other outcomes:
Locations:
city: Cary
country: United States
facility: True You Weight Loss
state: North Carolina
Study officials:
affiliation: True You Weight Loss
name: Christopher McGowan, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bulajic M, Vadala di Prampero SF, Boskoski I, Costamagna G. Endoscopic therapy of weight regain after bariatric surgery. World J Gastrointest Surg. 2021 Dec 27;13(12):1584-1596. doi: 10.4240/wjgs.v13.i12.1584.
citation: Lauti M, Kularatna M, Hill AG, MacCormick AD. Weight Regain Following Sleeve Gastrectomy-a Systematic Review. Obes Surg. 2016 Jun;26(6):1326-34. doi: 10.1007/s11695-016-2152-x.