NCT06790329

ESG With Fundal Mucosal Ablation

Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure. Recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. Combining endoscopic gastric fundus mucosal ablation with ESG could potentially enhance the weight loss effects of ESG while maintaining an acceptable safety profile. This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA) in obese patients eligible for endoscopic bariatric therapies.

Conditions

• Obesity and Obesity-related Medical Conditions

Interventions

Type	Name	Description
PROCEDURE	Endoscopic sleeve gastroplasty with fundal mucosal ablation	Mucosal ablation around the gastric fundus is initially performed using a hybrid argon plasma coagulation (H-APC) probe, following a submucosal saline injection, until ablation coagulum is visible. Subsequently, endoscopic sleeve gastroplasty (ESG) is performed using a full-thickness endoscopic suturing device (Overstitch, Apollo). This is done in a standard manner, employing 6-8 permanent full-thickness sutures along the greater curvature of the stomach in a running plication, starting from the angular incisura and extending proximally while sparing the fundus. Hemostasis is carefully checked and confirmed before the procedure is completed.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: Hong Kong