REvision of VSG with Ablation of the Mucosa Procedure

Recruiting now · Not applicable

Conditions studied: Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Obesity Prevention, Obesity Recidivism

In brief

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.

Key facts

Study ID

NCT06671119

Run by

Dr. Christopher McGowan

People needed

5

Starts

2024-12-01

Expected to finish

2026-05-01

Last updated by the study team

2024-11-05

Who can join

Age: 22 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients who have:
• BMI of 30 kg/m2 or greater, AND
• 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%
• Must have undergone SG at least three years before the time of enrollment
• Age range: 22 - 60 years
• 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.
• Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
• Must agree not to donate blood during participation in the study.
• Should be able to comply with study requirements, understand, and sign the Informed Consent Form.
• Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to the screening visit.
• Should have a history of failure to lose weight using conventional diet and lifestyle therapies.
• Must have reliable access to wifi and/or internet services.
• Must express willingness to comply with the substantial lifelong dietary restrictions required by the 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.
• Known history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel disease, such as Crohn's disease.
• 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.
• 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.
• 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.
• 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.
• Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea, or vomiting.
• 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).
• History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia.
• Current use of anticoagulation therapy.
• Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks post procedure.

Where it is running

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

Full record on ClinicalTrials.gov

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