Ensayos clínicos

Inclusion Criteria

• Age 22 - 65
• BMI ≥ 30 and <40
• Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
• History of obesity (BMI ≥ 30) for at least 2 years
• History of failure with non-surgical weight loss methods
• Willingness to follow protocol requirements, including
  • Signed informed consent
  • Routine follow-up schedule
  • Completing laboratory tests
  • Completing diet counseling
• Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow- up visits
• Ability to give informed consent
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  • Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence
  • The method of birth control must be documented and verified at follow-up
  • If a treatment subject becomes pregnant during the implantation period, the balloon will be extracted during the second trimester - the timing of which will be determined via consultation with the subject’s obstetrician   

Exclusion Criteria

• Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions
• Prior open or laparoscopic bariatric surgery
• Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery
• Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease
• Potential upper gastrointestinal bleeding condition such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses
• A gastric mass
• A hiatal hernia > 2cm 
• Severe or intractable gastro-esophageal reflux symptoms
• Acid reflux symptoms to any degree that require more than one medication for symptom control
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope
• Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
• Severe coagulopathy
• Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months
• Any serious health condition unrelated to weight that would increase the risk of endoscopy
• Chronic abdominal pain
• Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
• Hepatic insufficiency or cirrhosis
• 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 8 months
• Alcoholism or drug addiction
• Unwillingness to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up
• Receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants
• Unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant
• Known to have, or suspected to have, an allergic reaction to materials contained in the system
• Has ever developed a serotonin syndrome and is currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device
• Is pregnant or breast-feeding
• Has severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly-controlled hypertension, required use of NSAIDs
• Has tested positive for H. Pylori
• Is taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
• Is taking corticosteroids, immunosuppressants, or narcotics
• Is taking diet pills
• Use of an intragastric device prior to this study, due to the potential increase in risk associated with implantation of a balloon in a previously instrumented and possibly scarred stomach
• Participation in any clinical study which could affect weight loss within the past 6 months, due to the potential to confound findings
• Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
• Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or is immunocompromised
• Life expectancy less than 1 year or has severe renal, hepatic, pulmonary or other medical condition in the opinion of the investigator, because of an increased risk profile
• Specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or Prader Willi syndrome
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
• Known history of endocrine disorders affecting weight