Ensayos clínicos

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