A Post-Market Surveillance Study of Using the g-Cath EZ for Treating Obesity

Exclusion Criteria

• •1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
• •2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
• •3. Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
• •4. Large hiatal hernia (\>3 cm) by history or as determined by pre-enrollment endoscopy.
• •5. Pancreatic insufficiency/disease.
• •6. History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g. esophago-gastric motility issues and lower esophageal sphincter abnormalities).
• •7. Pregnancy or plans of pregnancy in the next 12 months.
• •8. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
• •9. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
• •10. Active gastric erosion, lesion, or gastric/duodenal ulcer.
• •11. History of or current platelet or coagulation dysfunction.
• •12. History or present use of insulin or insulin derivatives for treatment of diabetes.
• •13. Type II Diabetes Mellitus (as defined by HgbA1c \>6.5%) for greater than 11 years at the time of enrollment.
• •14. If smoker, plans to quit smoking in the year after enrollment.
• •15. Portal hypertension and/or varices.
• •16. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
• •17. Present or past history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
• •18. Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 1
• •19. Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
• •20. Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH \>5.0 U/ml).
• •21. Participating in another clinical study.
• •22. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
• •23. Physician's assessment that the subject is not an appropriate candidate. If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution's standard procedure.