Embospheres Microspheres for Non-Alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Alcoholic Fatty Liver Disease (NAFLD)+5 MoreEmbospheres Microspheres - Device
Eligibility
22 - 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Alcoholic Fatty Liver Disease (NAFLD)
  • Weight Loss
  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Non-Alcoholic Fatty Liver Disease
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 12 months

12 months
Change in inflammation, fibrosis, steatosis in liver histology
Clinical parameter- Abdominal circumference
Clinical parameter-Blood pressure
Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY)
Laboratory parameter-serum glucose
Laboratory parameters- HbA1c
Laboratory parameters-Lipid profile
NAFLD activity score
Number of patients with clincal adverse events
Number of patients with clinical adverse events
Results from endoscopy
Weight

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

NASH- Left gastric artery embolization
1 of 1

Experimental Treatment

8 Total Participants · 1 Treatment Group

Primary Treatment: Embospheres Microspheres · No Placebo Group · N/A

NASH- Left gastric artery embolization
Device
Experimental Group · 1 Intervention: Embospheres Microspheres · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Keith Pereira, MD:Lead Sponsor
Kirubahara Vaheesan, MDPrincipal InvestigatorAssistant professor of radiology- Interventional radiology
1 Previous Clinical Trials
8 Total Patients Enrolled
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

Eligibility Criteria

Age 22 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
: Total bilirubin <3 mg/dL The liver is functioning well.
Kidney function is normal, with an estimated GFR of more than 60 ml per minute.
Elevated alanine or aspartate aminotransferase values (more than 41 or 34 units per liter, respectively) indicate a problem with the liver.
The patient is eligible if they have a score of 16 or over on the CESD scale and if their behavior health specialist doesn't foresee any mental health issues that might prevent them from participating in the study.
If you are having the bariatric embolization procedure done through the femoral artery, your platelet count should be at least 50,000 per microliter, and your INR should be less than 1.5
Any person aged 22 years or older, regardless of their gender.
The subject is willing and able to provide written consent for the study and is willing to comply with all study procedures
A liver biopsy from a patient reveals evidence of NASH within the past 12 months.
There is no evidence of another form of liver disease.
References