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Device

Bariatric Artery Embolization for Fatty Liver Disease

N/A

Waitlist Available

Led By Brent Neuschwander-Tetri, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Weight

Secondary outcome measures

Change in inflammation, fibrosis, steatosis in liver histology

Clinical parameter- Abdominal circumference

Clinical parameter-Blood pressure

+7 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Keith Pereira, MD:Lead Sponsor

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for individuals to join this clinical trial?

"The information about this particular trial stored on clinicaltrials.gov reveals that it is not currently enrolling participants. Though the study was first posted June 1st of 2023 and last edited November 30th of 2022, 1480 other trials are still actively searching for volunteers."

Answered by AI

Does the study accept participants over 50 years of age?

"This particular clinical trial is only seeking participants between the ages of 22 and 65. There are 263 trials open to minors below 18 years old, while 1019 studies accept adults over 65."

Answered by AI

Am I able to sign up as a participant in this research endeavor?

"This trial requires 8 participants aged between 22 and 65 who are also clinically obese. Furthermore, the subjects must have a Centre for Epidemiological Studies Depression (CESD) score of at least 16 and be in treatment with a mental health specialist that has deemed them fit to participate without any psychological roadblocks. Lastly, they should either identify as male or female while having a Body Mass Index above 35 kilograms per meter squared."

Answered by AI