REVAMP Research Study

Are you seeking a less-invasive procedure to lose weight? Are you interested in contributing to evidence-based research?

True You Weight Loss is proud to be participating in the REVAMP clinical trial. This clinical trial aims to investigate whether ablating the gastric mucosa after vertical sleeve gastrectomy results in weight loss.

If you participate, the procedure is covered at no cost to you, and you will receive compensation for your participation.

If this study interests you, please read below and email us at research@trueyouweightloss.com with your contact information. Please note that enrollment for this study is competitive – patients are not guaranteed a spot in the study, even if they are eligible.

How to be considered for this clinical trial?

Key criteria to have:

• Male or female aged between 22 to 60 years old.
• BMI is 30 kg/m² or greater
• Previous recipient of vertical sleeve gastrectomy who has subsequently regained 25% or more of their previous weight loss.
• Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
• Agree not to donate blood during their participation in the study.
• Agree to comply with study requirements and procedures and understand and sign the informed consent form.
• Reliable access to WIFI and/or internet services.
• Be willing to comply with the substantial lifelong dietary restrictions required by the procedure.

Key criteria not to have:

• You should not be taking the following drugs:
  • Exogenous insulin or any type of insulin
  • Glucose lowering drugs, excluding sulfonylurea (SU), biguanides sodium-dependent glucose co-transporter 2 (SGLT-2) inhibitors
  • Anti-coagulation therapy
  • Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks after the procedure
  • Systemic glucocorticoids
  • Drugs known to affect GI motility (ie. Metoclopramide)
  • Weight loss medications (ie. Meridia, Xenical, Saxenda, Januvia, Duromine, or over the counter-weight loss medications)

• You should not have the following conditions:
  • Be pregnant or breast-feeding or intending to get pregnant during the study
    • Experience chronic upper abdominal pain, nausea, vomiting, dyspepsia, post-prandial fullness or pain, or have a history of gastric ulcer
    • Autoimmune disease
    • Diabetic gastroparesis
    • History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
    • 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
    • Active pylori infection
    • Significant cardiovascular disease
    • Known immunocompromised status
    • Active systemic infection
    • Known active malignancy within the last 5 years
    • Known multiple endocrine neoplasia syndrome type 1
    • Active illicit substance abuse or alcoholism
    • Current smoker or smoking history in the last 6 months
  • You should not have undergone upper GI surgery, other endoscopic bariatric procedures or conditions, intra-gastric balloon or gastric implants

How long would trial participation last?

From the time of study enrollment, your participation would last up to 15 months.

Where is this clinical trial being held?

The procedure will be carried out at True You Weight Loss, North Carolina (2001 Weston Parkway, Cary, NC 27513)

Will I be compensated?

Participants will be compensated for their time, effort, and inconvenience. This includes up to $1,700 in compensation and incentive payments. Participants will also receive the procedure at no cost.