Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

Inclusion criteria

• Subjects estimated to fully comply with study protocol and have signed an informed consent form.
• Age > 15 years.
• BMI ≥ 99. percentile for age and gender.
• Inefficient conservative measures (of at least 6 months duration) to decrease body weight (characterized as a decrease in BMI > 10 %).
• Documented negative pregnancy test in women of childbearing potential.
• Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.

Exclusion criteria

• Previous GI surgery that could potentially affect the ability to place sleeve or affect the function of the implant.
• Subjects with congenital or acquired anomalies of the GI tract which in the opinion of the investigator, may impair implantation of the EndoBarrier device.
• Subjects who had gastrooesophageal reflucs disease..
• Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, upper gastro-intestinal bleeding conditions.
• Coagulopathy defined as Hgb <10g/dl and platelet < 100,000/ml or diagnosis of other severe coagulopathy like hemophilia.
• Any documented history of acute or chronic pancreatitis.
• Subjects requiring regular antithrombotic therapy (i.e. anticoagulant or antiplatelet agent).
• Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
• Subject is or has been enrolled in another investigational study within 6 months of participation into the EndoBarrier study.
• Subjects who are mentally retarded or emotionally unstable.
• Subjects who are pregnant or were breastfeeding.
• Subjects with an abnormal laboratory or ECG abnormality which the investigators deems clinically significant and makes the patient a poor candidate for the study.