ObesityNCT02880189
EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity
A study testing Orbera Intragastric Balloon and Endoscopic Ultrasound Guided Core Liver Biopsy in people with Obesity and Non-Alcoholic Steatohepatitis, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 69 years
- Conditions the study is for
- Obesity, Non-Alcoholic Steatohepatitis
- What is being tested?
- Orbera Intragastric Balloon and Endoscopic Ultrasound Guided Core Liver Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 13 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity
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
- Being tested
- Orbera Intragastric Balloon, Endoscopic Ultrasound Guided Core Liver Biopsy
- Keywords
- Non-Alcoholic Steatohepatitis (NASH), NASH with Fibrosis, Intragastric Balloon, Orbera, Orbera Intragastric Balloon
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Endoscopic Ultrasound Guided Core Liver BiopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy. Receives: Device: Orbera Intragastric Balloon; Procedure: Endoscopic Ultrasound Guided Core Liver Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 6 months post-procedure
Secondary outcomes (1)
Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies
Total number of subjects correctly diagnosed with NASH and Early Fibrosis by EUS guided core liver biopsies
Measured: Baseline to 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startDec 2016
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barham K. Abu Dayyeh, M.D., Mayo Clinic
- Investigators
- Barham Abu Dayyeh, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880189
- Sponsor's protocol ID
- 15-009262
- Status last verified
- Jun 2022
- First submitted
- 23 Aug 2016
- Last updated
- 15 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32360804Bazerbachi 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.
PubMed 31437454
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity
- ClinicalTrials.gov ID
- NCT02880189
- Acronym / sponsor ID
- 15-009262
- Conditions
- Obesity, Non-Alcoholic Steatohepatitis
- Keywords
- Non-Alcoholic Steatohepatitis (NASH), NASH with Fibrosis, Intragastric Balloon, Orbera, Orbera Intragastric Balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Posted 18 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Device: Orbera Intragastric Balloon, Procedure: Endoscopic Ultrasound Guided Core Liver BiopsyAll subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy. |
Who may qualify
- Ages
- 22 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orbera Intragastric BalloonThe 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. | Device | Single |
| Endoscopic Ultrasound Guided Core Liver Biopsy | Procedure or surgery | Single |
Primary outcome
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. 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).
1 secondary outcome
Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies
Time frame: Baseline to 6 months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32360804Bazerbachi 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.
- Derived from this study: PubMed 31437454Bazerbachi 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barham Abu Dayyeh, M.D. principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Orbera Intragastric Balloon and Endoscopic Ultrasound Guided Core Liver Biopsy in people with Obesity and Non-Alcoholic Steatohepatitis, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss Achieved With Intragastric Balloon (IGB) (time frame: Baseline to 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880189, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.