Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
|ClinicalTrials.gov Identifier: NCT02556138|
Recruitment Status : Terminated (Unable to obtain a timely newly requested IDE)
First Posted : September 22, 2015
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Liver Cirrhosis||Device: ORBERA Intragastric Balloon||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates|
|Actual Study Start Date :||September 1, 2015|
|Actual Primary Completion Date :||November 3, 2016|
|Actual Study Completion Date :||November 3, 2016|
Experimental: Orbera Intragastric Balloon
All subjects will be receiving the ORBERA Intragastric Balloon
Device: ORBERA Intragastric Balloon
The ORBERA Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.
- Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months [ Time Frame: 6 months ]The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.
- Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal [ Time Frame: 6 months ]%TBWL at 6 months = Number of kg lost at 6 months/starting weight in kg
- Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal [ Time Frame: 6 months ]The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556138
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Kymberly Watt, M.D.||Mayo Clinic|