Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05611567
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Gastric Plication Using the POSE2.0 Technique for Management of Fatty Liver Disease
Sponsor:
Emirates Health Services (EHS)
Organization:
Study Overview
Official Title:
A Feasibility Study Examing the Primary Obesity Surgery Endoluminal (POSE) 2.0 Procedure for the Management of Non-alcoholic Fatty Liver Disease
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: