A Study of Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-003183
NCT ID: NCT02556138
Sponsor Protocol Number: 15-003183
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Adults (>18 years)
- 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 ≥ moderate/severe, gastric varices, or esophageal varices graded ≥ moderate/large (Patients with varices which have been obliterated may be included)
- Calculated 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kymberly Watt, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available