NCT05611567

Endoscopic Gastric Plication Using the POSE2.0 Technique for Management of Fatty Liver Disease

A Feasibility Study Examing the Primary Obesity Surgery Endoluminal (POSE) 2.0 Procedure for the Management of Non-alcoholic Fatty Liver Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Emirates Health Services (EHS) · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Obesity Surgery Endoluminal 2.0, or POSE 2.0, (USGI Medical, San Clemente, CA) creates full-thickness plications of gastric tissue endoscopically to shorten the stomach and narrow its aperture for weight loss in patients with obesity. Adults with obesity and non-alcoholic NAFLD were allocated based on preference and motivation to undergo the POSE 2.0 procedure with lifestyle modification or lifestyle modification alone to study the impact of the POSE2.0 procedures on NAFLD parameters and metabolic profile. Co-primary endpoints included improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary endpoints included total body weight loss (TBWL), change in serum measures of hepatic steatosis and insulin resistance, and device safety.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Obesity

Interventions

Type	Name	Description
PROCEDURE	POSE2.0 procedure	The POSE 2.0 involves full-thickness plications by suture anchor pairs that shorten and tabularize the stomach along its greater curvature. The POSE 2.0 procedure was carried out using the Incisionless Operating Platform (USGI Medical, San Clemente, CA)
BEHAVIORAL	Life style and behavioral intervention	The intervention focuses on caloric restriction diet, physical activity, and behavioral modification targeted toward weight loss and administered by a health care professional months for the 12 months duration of the study.

Timeline

• Start date: 2020-01-20
• Primary completion: 2022-03-15
• Completion: 2022-09-01
• First posted: 2022-11-10
• Last updated: 2022-11-10

Locations

1 site across 1 country: United Arab Emirates