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Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Kymberly D. Watt, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Liver Cirrhosis Device: ORBERA Intragastric Balloon Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with end-stage liver disease who are listed for liver transplant
  • Have failed the non-invasive approach to weight loss to be actively listed for transplant (requiring 2 clinical return visits without weight loss of >5 kg)
  • Body Mass Index (BMI) >35
  • Negative pregnancy test for females who are able to get pregnant and are of child-bearing age

Exclusion Criteria:

  • A previous history of gastric or bariatric surgery
  • Current or recent (within 6 months) gastric or duodenal ulcers
  • Moderate to severe Portal hypertension defined as portal gastropathy graded as >= to moderate/severe, gastric varices, or esophageal varices graded > = moderate/large (Patients with varices which have been obliterated may be included).
  • Calculated Model of End-stage Liver Disease (MELD) score >25 or childs score >10
  • The presence of more than one gastric balloon at the same time
  • Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
  • A large hiatal hernia or >5 cm hernia or ≤5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
  • Achalasia or any other severe motility disorder that may pose a safety risk during removal of the device.
  • Gastric mass
  • Severe coagulopathy
  • Patients who are known to have or suspected to have an allergic reaction to materials contained in ORBERA.
  • Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.
  • Alcoholism or drug addiction
  • Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant
  • Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  • Patients receiving aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, not under medical supervision.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556138


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Kymberly Watt, M.D. Mayo Clinic
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Responsible Party: Kymberly D. Watt, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02556138    
Other Study ID Numbers: 15-003183
First Posted: September 22, 2015    Key Record Dates
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kymberly D. Watt, Mayo Clinic:
Intragastric Balloon
ORBERA Intragastric Balloon
Weight Loss
BMI >35
Additional relevant MeSH terms:
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Liver Cirrhosis
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Liver Diseases
Digestive System Diseases