Combined Fundic Ablation and ESG for Obesity
(AW2 Trial)

Recruiting in Palo Alto (17 mi)

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 combined effects of fundic ablation (FA) and endoscopic sleeve gastroplasty 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. When fundic mucosal ablation is 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 within the same endoscopic session 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 travel to Cary, North Carolina, have internet access, and not be pregnant or planning pregnancy during the study. Exclusions include prior stomach surgery, certain medical conditions like uncontrolled diabetes or gastroparesis, use of specific medications affecting digestion or blood clotting, and allergies to milk/soy.

Inclusion Criteria

I am between 21 and 65 years old.

Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²

I can travel to and from Cary, North Carolina easily.

+5 more

Exclusion Criteria

Patients who are pregnant or who plan to become pregnant during study duration

I am currently taking medication to help me lose weight.

I have a history of stomach or bowel problems like IBS.

+12 more

Participant Groups

The trial tests a combined procedure for weight loss: fundic ablation (FA) plus endoscopic sleeve gastroplasty (ESG). FA uses thermal injury on the stomach's gastric fundus to reduce ghrelin hormone levels that increase appetite. ESG reshapes the stomach. Together they aim to enhance satiation and promote more weight loss than ESG alone.

1Treatment groups

Experimental Treatment

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

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session