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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880189
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Barham K. Abu Dayyeh, M.D., Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Non-Alcoholic Steatohepatitis Device: Orbera Intragastric Balloon Procedure: Endoscopic Ultrasound Guided Core Liver Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 13, 2018
Actual Study Completion Date : March 13, 2018


Arm Intervention/treatment
Single
All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
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



Primary Outcome Measures :
  1. Weight Loss Achieved With Intragastric Balloon (IGB) [ Time Frame: Baseline to 6 months post-procedure ]
    Total number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters


Secondary Outcome Measures :
  1. Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies [ Time Frame: Baseline to 6 months post-procedure ]
    Total number of subjects correctly diagnosed with NASH and Early Fibrosis by EUS guided core liver biopsies



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with Non-alcoholic Steatohepatitis with early evidence of fibrosis as seen on MRE-hepatogram
  • Referred clinically for an intragastric balloon placement for weight loss

Exclusion Criteria:

  • Women who are pregnant or plan to be pregnant or are breastfeeding
  • Previous history of gastric surgery
  • Current or recent (within 6 months) gastric or duodenal ulcers
  • Gastroparesis
  • Liver cirrhosis
  • Coagulopathy or active use of coagulation
  • Inability to provide a written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880189


Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Barham Abu Dayyeh, M.D. Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Barham K. Abu Dayyeh, M.D., Mayo Clinic:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barham K. Abu Dayyeh, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02880189    
Other Study ID Numbers: 15-009262
First Posted: August 26, 2016    Key Record Dates
Results First Posted: April 18, 2019
Last Update Posted: April 18, 2019
Last Verified: March 2019
Keywords provided by Barham K. Abu Dayyeh, M.D., Mayo Clinic:
Non-Alcoholic Steatohepatitis (NASH)
NASH with Fibrosis
Intragastric Balloon
Orbera
Orbera Intragastric Balloon
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Liver Diseases
Digestive System Diseases