ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss) (AW2)
Obesity
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria: Subjects aged 21-65 Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m² History of at least one unsuccessful dietary effort to lose body weight Willing and able to participate in the study procedures Understand and voluntarily sign the informed consent Approved ESG candidate at True You Weight Loss Access to internet Reliable transportation to and from Cary, North Carolina surrounding area Exclusion Criteria: Younger than 21 years of age Older than 65 years of age Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels Milk and/or soy allergies History of any stomach manipulation (including repair of hiatal hernia) History of disordered eating Patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason Hemoglobin A1c > 7.0 or any patient with symptoms suggestive of gastroparesis or a formal diagnosis of gastroparesis Patients taking the following medications known to impair gastric accommodation: buspirone, mirtazapine Patients taking the following medications known to accelerate or impair gastric emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride), erythromycin, Motilium (domperidone), opiates, anticholinergic agents Patients who are pregnant or who plan to become pregnant during study duration Use of non-steroidal anti-inflammatory medications without the ability to stop these during study duration Patients on chronic anticoagulation History of functional gastrointestinal disorder, including functional dyspepsia, irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor function. Concurrent use of weight loss medications.
Sites / Locations
- True You Weight LossRecruiting
Arms of the Study
Arm 1
Experimental
Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty
Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session