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New treatment option for Obesity and Obesity-related Medical Conditions
Official title REvision of VSG with Ablation of the Mucosa Procedure
ClinicalTrials.gov ID: NCT06671119
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 60
You may be able to join 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...
- Must have undergone SG at least three years before the time of enrollment
- Age range: 22 - 60 years
You likely can't join 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...
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
See the full eligibility criteria
Who can join
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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 (people 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.
- 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.
- Use of drugs known to affect GI motility (e.g., Metoclopramide).
- 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.
- 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...
- Persistent Anemia, defined as Hemoglobin \<10 g/dL.
- 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.
- Known moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m2 (estimated by MDRD).
- 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...
- Active systemic infection.
- Known active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma).
- people with an established diagnosis of Multiple Endocrine Neoplasia syndrome type 1.
- Not a candidate for surgery or general anesthesia.
- Active illicit substance abuse or alcoholism.
- Current smoker or smoking history in the last six months.
- Participating in another ongoing clinical trial of an investigational drug or device.
- Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.
- Other medical conditions that do not allow for an endoscopic procedure.
The study team makes the final eligibility decision.
Where it's taking place
- Cary, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cary, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.