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Device

Bariatric Artery Embolization for Fatty Liver Disease

N/A
Waitlist Available
Led By Keith Pereira, MD
Research Sponsored by Keith Pereira, MD:
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hepatic function: Total bilirubin <3 mg/dL
Center for Epidemiological Studies Depression (CESD) score > or =16 AND in care of behavior health specialist with adequate coping mechanisms
Must not have
Metastatic cancer
Prior embolization to specific organs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying Left gastric artery embolization (LGAE) to see if it can help patients with obesity and NASH lose weight and improve their NASH.

Who is the study for?
This trial is for adults aged 22 or older with obesity (BMI >35 kg/m2) and diagnosed with NASH, who haven't succeeded in losing weight through diet, exercise, or behavior modification. They should have tried other weight loss methods without success and have a liver biopsy confirming NASH within the last year. Participants need to be mentally fit to consent and follow study procedures.
What is being tested?
The trial tests if blocking blood vessels leading to the stomach using Embospheres Microspheres can reduce appetite hormone levels, cause significant weight loss, and improve conditions of NASH in obese patients.
What are the potential side effects?
Potential side effects may include abdominal pain due to the procedure itself, risks associated with embolization such as infection or bleeding at the access site, possible allergic reactions to materials used during embolization, and less commonly changes in gastric function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is working well, with bilirubin levels below 3 mg/dL.
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I have a depression score of 16 or higher and am seeing a mental health specialist.
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I do not have any other liver diseases.
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My kidney function is good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to other parts of my body.
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I have had a procedure to block blood flow to certain organs.
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My weight is over 400 lbs or my BMI is over 50.
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I have ongoing stomach pain.
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I need blood-thinning medication and cannot have treatments through my wrist.
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My liver is not working properly.
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I have had surgery to lose weight.
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My liver disease is severe.
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I have type 2 diabetes and am on medication for it.
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I have unusual body structures or severe artery disease.
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I have a known condition affecting my aorta or peripheral arteries.
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I cannot have a liver biopsy due to health reasons.
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I cannot stop taking aspirin or NSAIDs for a certain time.
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I am currently taking medication that can harm my liver.
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I cannot have a liver biopsy due to health risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weight
Secondary study objectives
Change in inflammation, fibrosis, steatosis in liver histology
Clinical parameter- Abdominal circumference
Clinical parameter-Blood pressure
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NASH- Left gastric artery embolizationExperimental Treatment1 Intervention
Embospheres Microspheres as artificial embolic agent for left gastric artery embolization

Find a Location

Who is running the clinical trial?

Keith Pereira, MD:Lead Sponsor
Keith Pereira, MDPrincipal InvestigatorAssistant professor of radiology-Interventional radiology
3 Previous Clinical Trials
246 Total Patients Enrolled
Brent Neuschwander-Tetri, MDPrincipal InvestigatorProfessor of medicine- gastroenterology
Kirubahara Vaheesan, MDPrincipal InvestigatorAssistant professor of radiology- Interventional radiology
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Embospheres Microspheres (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02933554 — N/A
Non-alcoholic Fatty Liver Disease Research Study Groups: NASH- Left gastric artery embolization
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Embospheres Microspheres Highlights & Side Effects. Trial Name: NCT02933554 — N/A
Embospheres Microspheres (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02933554 — N/A
~5 spots leftby Jun 2026
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