What is this clinical trial about?
This clinical trial aims to investigate whether this experimental treatment involving the ablation of up to 70% of the gastric mucosa would result in weight loss.
How to be considered for this clinical trial?
Key criteria to have:
Male or female aged between 22 to 60 years old.
BMI falls within the range of Class I to Class III obesity (30 ≤ BMI ≤ 40 kg/m2 with obesity-related comorbidity or 40 < BMI ≤ 45 kg/m2).
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.
A history of failure to lose weight using conventional diet and lifestyle therapies.
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 types 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
- Autoimmune disease, excluding autoimmune thyroid disease which is adequately replaced
- 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 3 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 (Raleigh Endoscopy Centre, 2001 Weston Parkway, Cary, NC 27513)
Will I be compensated?
Participants will be compensated for their time, effort, and inconvenience. This includes up to $2,800 in compensation and incentive payments. Participants will also receive the procedure at no-cost.
Additional information about the study can be accessed via ClinicalTrials.gov.
Study status: enrollment complete; findings pending
