Combined Ablation and ESG for Obesity

Recruiting in Palo Alto (17 mi)

Overseen byChristopher E McGowan, MD, MSCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: True You Weight Loss

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research is to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation, and total body weight loss, as well as the incidence of adverse events. This procedure will be carried out with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument creates an electric current to deliver a safe amount of thermal injury to a portion of the stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin which is the only known hormone linked to increasing appetite, calorie intake, and weight gain. This procedure is designed to target the bodily effects of appetite control and gastric sensory and motor functions which cause the feeling of fullness and satiation. The fundic mucosal ablation is not typically done prior to the endoscopic sleeve gastroplasty procedure. When fundic mucosal ablation is sequentially paired with endoscopic sleeve gastroplasty (ESG), this combined investigational approach may lead to decreased fasting ghrelin levels, improved satiation, and greater total body weight loss than traditional ESG. This study will help determine if the combined impact of FA with ESG should be made available to patients as part of a comprehensive weight loss strategy.

Eligibility Criteria

This trial is for adults aged 21-65 with a BMI of 30-50 who have tried and failed to lose weight through dieting. They must be able to access the internet, travel to Cary, NC, and not be on certain medications or have conditions affecting stomach function. Pregnant individuals or those planning pregnancy during the study are excluded.

Inclusion Criteria

I can travel to and from Cary, North Carolina for the trial.

I am between 21 and 65 years old.

History of at least one unsuccessful dietary effort to lose body weight

+5 more

Exclusion Criteria

I am not taking buspirone or mirtazapine.

I am under 21 years old.

Milk and/or soy allergies

+12 more

Participant Groups

The trial tests if fundic ablation (FA) followed by endoscopic sleeve gastroplasty (ESG) leads to better appetite control and more weight loss than ESG alone. FA targets ghrelin, a hormone that increases appetite; this combination could improve satiation and reduce body weight.

1Treatment groups

Experimental Treatment

Group I: Gastric Fundic Ablation plus Endoscopic Sleeve GastroplastyExperimental Treatment3 Interventions

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty