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EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity

NCT02880189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-06-15

Study results available
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Summary

This study is designed to investigate the impact of weight loss achieved with the IGB on NASH with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having NASH with early fibrosis based on magnetic resonance elastography (MRE)-Hepatogram. In addition, this study will explore potential non-invasive imaging criteria for NASH and early fibrosis using EUS-Elastography.

Conditions

  • Obesity
  • Non-Alcoholic Steatohepatitis

Interventions

DEVICE

Orbera Intragastric Balloon

The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.

PROCEDURE

Endoscopic Ultrasound Guided Core Liver Biopsy

Sponsors & Collaborators

Principal Investigators

  • Barham Abu Dayyeh, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-03-13
Completion
2018-03-13

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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 NCT02880189 on ClinicalTrials.gov