Screened Health Assessment & Pacer Evaluation

Who cannot join

• 1) Patients who are excluded by the screening algorithm18, 19, 22 (Appendix C) 2) Patients scoring 29 or higher on the Binge Eating Scale Questionnaire (Appendix F) 3) Patients will undergo a psychological evaluation by a licensed psychologist or psychiatrist (Appendix D). Patients who are substance abusers or are identified as having borderline personality, bipolar disorder, or any other disorder that would make them inappropriate candidates, in the opinion of the psychologist/psychiatrist.
• 4) Pregnant or lactating females 5) Prior surgery of GI tract as therapy for obesity 6) Prior surgery on the stomach for any reason 7) Other electrical stimulation devices 8) Patients with known history or under treatment for ulcers 9) Patients with a clinically significant hiatal hernia 10) Patients with motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation 11) Patients taking any weight loss medication or other drugs that can affect body weight (e.g. mirtazapine, laxatives, systemic glucocorticoids, neuroleptic agents, progestational steroids) within three months prior to screening 12) Patients who require continuous therapy with known ulcerogenic medication (e.g., aspirin, non-steroidal anti-inflammatory agents, COX-2 inhibitors) 13) Patients with a history of cardiac arrhythmia or severe cardiac disease (NYHA class III or IV) 14) Type I diabetes and poorly controlled Type II diabetes as evidenced by an HbA1c level greater than 10%. Those patients with an HbA1c between 8% and 10% and who have ongoing symptoms of hyperglycemia, including unexplained weight loss or significant polyuria, polydipsia, or a fasting glucose level above 180 mg/dl within 5 days prior to implantation, will be excluded.
• If the fasting glucose level is above 180 mg/dl during screening, the patient will not be excluded from the study but be treated for hyperglycemia. Laboratory tests, including a fasting glucose level, will be repeated for all patients within 5 days prior to implantation.
• 15) Any diabetic patients on non-steady treatment with thiazolidinediones (Actos or Avandia) within past three months prior to screening 16) Patients with a history of Barrett's esophagus 17) Patients who have severe weight-related co-morbid diseases that require immediate weight loss (e.g., life-threatening sleep apnea) 18) Patients with any serious health condition not related to their weight 19) Use of another investigational agent within 30 days prior to screening 20) Patients whom the investigator or study coordinator considers to be unable or unwilling to fulfill study requirements