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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02556138
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Liver Cirrhosis	Device: ORBERA Intragastric Balloon	N/A

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.

Study Design

• Study Type: Interventional
• 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: Sep 1, 2015
• Actual Primary Completion Date: Nov 3, 2016
• Actual Study Completion Date: Nov 3, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Kymberly Watt, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kymberly D. Watt, PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02556138
• Other Study ID Numbers: 15-003183
• First Posted: Sep 22, 2015
• Last Update Posted: Jan 30, 2018
• Last Verified: Jan 1, 2018

• 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, PI, Mayo Clinic: Intragastric Balloon; ORBERA Intragastric Balloon; Weight Loss; BMI >35
• Additional relevant MeSH terms: Liver Cirrhosis; Weight Loss

Study Results

Participant Flow

Recruitment Details	All subjects were recruited at the Mayo Clinic in Rochester, Minnesota.

Arm/Group Title	Orbera Intragastric Balloon
Arm/Group Description	All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Period Title: Overall Study
STARTED	8
COMPLETED	7
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Orbera Intragastric Balloon
Arm/Group Description	All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Overall Participants	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56 (4.6)
Sex: Female, Male (Count of Participants)
Female	1 12.5%
Male	7 87.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent to treat analysis

Arm/Group Title	Orbera Intragastric Balloon
Arm/Group Description	All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Measure Participants	8
Count of Participants [Participants]	8 100%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent to treat analysis

Arm/Group Title	Orbera Intragastric Balloon
Arm/Group Description	All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Measure Participants	8
Mean (Standard Deviation) [percentage of weight loss]	12.3 (8.1)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent to treat analysis

Arm/Group Title	Orbera Intragastric Balloon
Arm/Group Description	All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Measure Participants	8
Mean (Standard Deviation) [percentage of weight loss]	26.3 (16.8)

Adverse Events

Time Frame	6 months
Arm/Group Title	Orbera Intragastric Balloon
Arm/Group Description	All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
All Cause Mortality
	Orbera Intragastric Balloon
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	Orbera Intragastric Balloon
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Orbera Intragastric Balloon
	Affected / at Risk (%)	# Events
Total	6/8 (75%)
Gastrointestinal disorders
Balloon intolerance	1/8 (12.5%)	1
Retching	2/8 (25%)	2
General disorders
Mallory-Weiss tears	2/8 (25%)	2
Hepatobiliary disorders
Liver decompensation	2/8 (25%)	2
Hepatocellular carcinoma	2/8 (25%)	2

Limitations/Caveats

The study terminated early as unable to obtain a timely newly requested investigational device exemption (IDE).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.