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

NCT05611567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-11-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Emirates Health Services (EHS)

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2022-03-15
Completion
2022-09-01

Countries

  • United Arab Emirates

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611567 on ClinicalTrials.gov