Gastric fundal mucosal ablation followed by endoscopic sleeve gastroplasty in adults with obesity: a first-in-human two-phase pilot clinical trial.
Sanjay R V Gadi, Daniel B Maselli, Lauren L Donnangelo et al.
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In 30 seconds
This prospective, first-in-human, two-phase pilot clinical trial evaluated sequential gastric fundal mucosal ablation (GFMA) followed by endoscopic sleeve gastroplasty (ESG) in 10 adults with obesity. Participants underwent GFMA, received ESG six months later, and were followed for 12 months after ESG. Mean total body weight loss was 22.5% (SD 8.3%) at month 18. Appetite-related behaviors and eating self-efficacy improved, and maximum tolerated volume remained suppressed. Fasting plasma ghrelin decreased at month 6 but moved back toward baseline by month 18. No serious adverse events were reported.
Key findings
- Mean total body weight loss was 22.5% (SD 8.3%) at month 18.
- Maximum tolerated volume remained suppressed through month 18, while fasting plasma ghrelin moved back toward baseline.
- Hunger-related behaviors and eating self-efficacy showed sustained improvement.
- No serious adverse events occurred.
Why it matters
The findings suggest that combining fundal mucosal ablation with ESG may produce substantial weight loss alongside persistent changes in tolerated meal volume and improved appetite-related measures. The results add early clinical evidence for a sequential endoscopic approach, while the small pilot experience means its effectiveness and safety require confirmation in larger studies.
What to keep in mind
This was a first-in-human pilot trial involving only 10 participants, limiting the certainty and generalisability of its findings.