NCT07186959

EGPSS for Weight Management in an in Vivo Human Model

A Novel Endoscopic Gastric Purse-string Suture Device for Weight Management in an in Vivo Human Model

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Liu Yan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

ndoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management. Mucosal ablation of the gastric fundus has been reported to limit fundic expansion and promote satiety; however, ablation can cause perforation, infection, bleeding, and other complications. To restrain fundic expansion while minimizing surgical trauma and preserving reversibility, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce gastric volume. This procedure may be suitable for short-term weight management. Safety and feasibility were demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

Detailed description

The global prevalence of obesity has increased over the past five decades. Endoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management and have emerged as promising alternatives for treating obesity and related metabolic disorders (including type 2 diabetes and nonalcoholic fatty liver disease). Christopher et al. reported that ablation of the gastric fundus mucosa induces mucosal fibrosis; the resulting fibrotic tissue impedes fundic expansion and promotes satiety. However, fundic mucosal ablation may cause extensive and irreversible injury, increasing the risks of perforation, infection, bleeding, and other complications. A minimally invasive endoscopic therapy that inhibits fundic expansion while minimizing surgical trauma and preserving reversibility is therefore desirable. Based on this rationale, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce the volume of the gastric fundus. EGPSS employs a specially designed endoclip in combination with an endoloop to appose the fundic mucosa and restrict fundic expansion. This procedure may be suitable for short-term weight management. Safety and feasibility have been demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

Conditions

• Obesity, Mild

Interventions

Type	Name	Description
PROCEDURE	endoscopic gastric purse-string suturing	A dual-tail endoloop will be introduced into the stomach with endoscopic forceps, and will be secured to the gastric wall using endoscopic clips. An endoscope hook was used to tighten both tails of the endoloop until all the clips converged.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: China