Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorKeith Pereira, MD:

About this trial

Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant.

Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads to clinically significant weight loss with improvement of NASH.

Eligibility criteria

Qualifiers

Male or Female, aged 22 years or older.

Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study

BMI >35 kg/m2

Hematological: Hematological: If the bariatric embolization procedure is being performed by femoral access: platelets > 50 x 109/L, INR <1.5. If the bariatric embolization procedure is being performed by radial access: platelets >35 x 109/L and INR <1.5 OR platelets >50 x 109/L and INR between 1.5 and 2."

Disqualifiers

Pregnancy

Active substance abuse

Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score > or = 16 without psychiatric evaluation. [If Center for Epidemiological Studies Depression (CESD) score > or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.]

Significant alcohol consumption ( >20 g/day in women, >30 g/day in men)

Trial design

Treatments tested in this trial

  • Embospheres Microspheres

Treatment groups

8 Participants
are divided into 1 treatment group

Sponsors and collaborators

Keith Pereira, MD:

Lead sponsor

St. Louis University

Sponsor institution