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

Primary Purpose

Obesity, Liver Cirrhosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ORBERA Intragastric Balloon
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Intragastric Balloon, ORBERA Intragastric Balloon, Weight Loss, BMI >35

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orbera Intragastric Balloon

Arm Description

All subjects will be receiving the ORBERA Intragastric Balloon

Outcomes

Primary Outcome Measures

Number of Subjects With >= 15% Excess Body Weight Loss at 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

Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal
%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
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.

Full Information

First Posted
September 18, 2015
Last Updated
January 4, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02556138
Brief Title
Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
Official Title
Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to obtain a timely newly requested IDE
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
November 3, 2016 (Actual)
Study Completion Date
November 3, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Liver Cirrhosis
Keywords
Intragastric Balloon, ORBERA Intragastric Balloon, Weight Loss, BMI >35

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orbera Intragastric Balloon
Arm Type
Experimental
Arm Description
All subjects will be receiving the ORBERA Intragastric Balloon
Intervention Type
Device
Intervention Name(s)
ORBERA Intragastric Balloon
Intervention Description
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 Measure Information:
Title
Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal
Description
%TBWL at 6 months = Number of kg lost at 6 months/starting weight in kg
Time Frame
6 months
Title
Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kymberly Watt, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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