Ablate Weight II Study

(Developed and led by True You Weight Loss)

True You is excited to have launched a new study developed and led by our True You Research Team, for those interested in ESG and contributing to evidence-based research.

• Who: Patients seeking an ESG procedure with True You.
  • Key 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 TYWL
    • Access to internet
    • Reliable transportation
    • Those who plan to receive an endoscopic sleeve gastroplasty at True You facility regardless of the research
  • Key Exclusion Criteria:
    • 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
    • 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.
  • What: This study aims to evaluate a new technique called gastric fundic ablation to reduce hunger when combined with ESG in a single-stage, same day procedure.
  • When: From the time of study enrollment, your participation would last up to 15 months. This includes 3 months for screening assessments and 12 months for active study participation activities.
  • The procedure will be carried out at the True You Weight Loss clinic in Cary (2001 Weston Parkway, Cary, NC 27513).
  • Why: To investigate a new technique that may reduce hunger and may boost the weight loss seen with ESG.
  • Compensation: Participants will be responsible for the cost of the ESG procedure but will be compensated for their study-related time, effort, and inconvenience with non-monetary as well as monetary means. This includes up to $1,900 in compensation and incentive payments.

Additional information about the study can be accessed via ClinicalTrials.gov.

Study status: enrollment complete; findings pending