NCT02880189

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 18, 2019

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

August 23, 2016

Results QC Date

March 28, 2019

Last Update Submit

June 13, 2022

Conditions

ObesityNon-Alcoholic Steatohepatitis

Keywords

Non-Alcoholic Steatohepatitis (NASH)NASH with FibrosisIntragastric BalloonOrberaOrbera Intragastric Balloon

Outcome Measures

Primary Outcomes (1)

  • Weight Loss Achieved With Intragastric Balloon (IGB)

    Total number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters. The NAS scale can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2).

    Baseline to 6 months post-procedure

Secondary Outcomes (1)

  • Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies

    Baseline to 6 months post-procedure

Study Arms (1)

Single

OTHER

All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.

Device: Orbera Intragastric BalloonProcedure: Endoscopic Ultrasound Guided Core Liver Biopsy

Interventions

Orbera Intragastric BalloonDEVICE

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.

Single
Endoscopic Ultrasound Guided Core Liver BiopsyPROCEDURE
Single

Eligibility Criteria

Age22 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bazerbachi F, Vargas EJ, Rizk M, Maselli DB, Mounajjed T, Venkatesh SK, Watt KD, Port JD, Basu R, Acosta A, Hanouneh I, Gara N, Shah M, Mundi M, Clark M, Grothe K, Storm AC, Levy MJ, Abu Dayyeh BK. Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2021 Jan;19(1):146-154.e4. doi: 10.1016/j.cgh.2020.04.068. Epub 2020 Apr 30.

    PMID: 32360804DERIVED

  • Bazerbachi F, Vargas EJ, Matar R, Storm AC, Mounajjed TM, Topazian MD, Levy MJ, Chandrasekhara V, Abu Dayyeh BK. EUS-guided core liver biopsy sampling using a 22-gauge fork-tip needle: a prospective blinded trial for histologic and lipidomic evaluation in nonalcoholic fatty liver disease. Gastrointest Endosc. 2019 Dec;90(6):926-932. doi: 10.1016/j.gie.2019.08.006. Epub 2019 Aug 19.

    PMID: 31437454DERIVED

Related Links

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Dr. Barham K. Abu Dayyeh
Organization
Mayo Clinic
AbuDayyeh.Barham@mayo.edu
507-284-1825

Study Officials

  • Barham Abu Dayyeh, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

December 1, 2016

Primary Completion

March 13, 2018

Study Completion

March 13, 2018

Last Updated

June 15, 2022

Results First Posted

April 18, 2019

Record last verified: 2022-06