Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
Condition: Obesity
MeSH terms: Obesity
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: 19.0
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 can be
      reimplanted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years and < 55 years - Male or Female

          -  Previously implanted with the EndoBarrier Gastrointestinal Liner

          -  Subjects willing to comply with trial requirements

          -  Subjects who have signed an informed consent form

          -  Women who are post-menopausal, surgically sterile or on oral contraceptives for the
             duration of the study and who do not plan on becoming pregnant during the course of
             the trial.

        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

          -  Subjects 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.

          -  Subjects with active and uncontrolled gastroesophageal reflux disease (GERD)

          -  Subjects with symptomatic kidney stones prior to implant

          -  Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)

          -  Subjects with 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

          -  Subjects with symptomatic gallstones prior to implant

          -  Symptomatic coronary artery disease or pulmonary dysfunction

          -  Known infection (Subjects who have a known infection at time of screening can be
             enrolled if the infection is treated prior to their procedure; if they still have an
             infection on day of procedure they must be withdrawn)

          -  History of congenital or acquired anomalies of the gastrointestinal tract such as
             atresias or stenoses

          -  Pancreatitis or other serious organic conditions

          -  Subjects requiring prescription anticoagulation therapy

          -  Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during
             the implant period

          -  Subject 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.

          -  Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior
             history of H. Pylori and were successfully treated or are diagnosed during baseline
             tests and undergo successful treatment before their procedure)

          -  Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding
             conditions such as esophageal or gastric varices, congenital or acquired intestinal
             telangiectasia