Patients with iron deficiency and iron deficiency anemia
Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
Treatment represents an unreasonable risk to the patient
Pancreatitis or other serious organic conditions
Symptomatic coronary artery disease or pulmonary dysfunction
Patients with known gallstones prior to implant
Known infection at the time of implant
Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
Congenital or acquired anomalies of the GI tract such as atresias or stenoses
Pregnant or has the intention of becoming pregnant in the next 12 months
Unresolved alcohol or drug addiction
HIV Positive patients
Patients with hepatitis B or C
Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial
Previous GI surgery that could affect the ability to place the sleeve or the function of the implant.
Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
Patients receiving weight loss medications such as Meridia and Xenical
Family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
Patients with gastroesophageal reflux disease (GERD)
Patients with a history of kidney stones
Participating in another ongoing investigational clinical trial
Clareo Health | A Multicenter Study for Pre-Surgical Weight Loss
