Study for Short Term Weight Loss in Candidates for Bariatric Surgery
Condition: Obesity
MeSH terms: Weight Loss
Intervention: Endobarrier Liner
Intervention description: Medical device placed endoscopically in the duodenum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: obesity

Summary:

      The purpose of this study is to determine whether the GI Endobarrier Liner is safe and
      effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years and < 55 years - Male or Female

          -  BMI > 35 with significant comorbidities (i.e. hypertension, or hyperlipidemia, or
             diabetes) or > 40 BMI <60 (with or without a co-morbid condition)

          -  History of failure with nonsurgical weight loss methods

          -  Candidates for Roux-en-Y gastric bypass

          -  Willing to comply with trial requirements

          -  Signed an ICF

          -  Post-menopausal women with surgical sterilization or following any treatment or family
             planning and not planning to become pregnant during the course of the investigation

        Exclusion Criteria:

          -  Treatment represents an unreasonable risk to the subject

          -  Pregnant or have intention of becoming pregnant for the duration of the trial

          -  Unresolved alcohol or drug addiction

          -  Receiving weight loss medications (prescription, over-the-counter, or herbal dietary
             medications)

          -  Previous gastrointestinal surgery that could affect the ability to place the
             EndoBarrier Liner or the function of the implant

          -  Active GERD

          -  Symptomatic kidney stones prior to implant

          -  Iron deficiency and/or iron deficiency anemia

          -  History of Inflammatory bowel disease or condition of the gastrointestinal tract, such
             as ulcers or Crohn's disease

          -  Symptomatic gallstones prior to implant

          -  Symptomatic coronary artery disease or pulmonary dysfunction

          -  Known infection at the time of implant

          -  History of congenital or acquired anomalies of the gastrointestinal tract such as
             atresias or stenoses

          -  Pancreatitis or other serious organic conditions

          -  Requiring prescription anticoagulation therapy

          -  Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the
             implant period

          -  Having or Family history of a known diagnosis or pre-existing symptoms of systemic
             lupus erythematosus, scleroderma or other autoimmune connective tissue disorder

          -  Participating in another ongoing investigational clinical trial

          -  Mentally retarded or emotionally unstable, or exhibits psychological characteristics
             requiring medication that affects appetite (i.e. tricyclic antidepressants and
             atypical antipsychotic medications) which, in the opinion of the Investigator, makes
             the subject a poor candidate for device placement or clinical trial

          -  Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history
             of H. Pylori and were successfully treated)

          -  Having or a history of coagulopathy, upper gastro-intestinal bleeding conditions such
             as esophageal or gastric varices, congenital or acquired intestinal telangiectasia