Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05611567
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2022-10-27
Brief Title:
Endoscopic Gastric Plication Using the POSE20 Technique for Management of Fatty Liver Disease
Sponsor:
Emirates Health Services EHS
Organization:
Emirates Health Services EHS
Study Overview
Official Title:
A Feasibility Study Examing the Primary Obesity Surgery Endoluminal POSE 20 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 20 or POSE 20 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 20 procedure with lifestyle modification or lifestyle modification alone to study the impact of the POSE20 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:
None
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?:
None