Obesity Clinical Trial
Official title:
Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.
The prevalence of obesity and non-alcoholic steatohepatitis (NASH) in the general population
is increasing. More and more patients with underlying NASH-related cirrhosis are now being
referred to transplant centers but are not candidates for a potentially lifesaving liver
transplantation due to their obesity and comorbidities related to the obesity.
The investigators proposed a clinical pilot study using the new FDA approved intragastric
balloon in obese patients (BMI >35) with cirrhosis in need of liver transplantation, to
assess weight loss and metabolic improvement.
The ORBERA™ Intragastric Balloon is an elastic spherical balloon made of silicone, filled
with 650ml of saline solution. The deflated balloon comes preloaded on a catheter, which is
advanced transorally into the stomach. An endoscope is then advanced alongside it to ensure
accurate placement of the balloon in the fundus. Under direct visualization, the balloon is
then inflated by injecting saline solution mixed with methylene blue through the external
portion of the catheter. The ORBERA™ Intragastric Balloon is implanted for 6 months and then
retrieved endoscopically by puncturing the balloon with a needle, emptying the fluid content,
and removing it through the mouth. Both placement and removal of the ORBERA™ Balloon are done
as an outpatient procedure with monitored or general anesthesia.
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