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

Obesity Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05611567
Study type Interventional
Source Emirates Health Services (EHS)
Contact
Status Completed
Phase N/A
Start date January 20, 2020
Completion date September 1, 2022
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