Transoral Gastroplasty for the Treatment of Morbid Obesity

Exclusion Criteria

• •1. Hormonal or genetic cause for the obese state.
• •2. History of cancer other than localized basal cell carcinoma.
• •3. History of inflammatory disease of the gastrointestinal tract including Crohn's disease, ulcerative colitis, severe intractable esophagitis, gastric ulceration, or esophageal or duodenal ulceration.
• •4. Active peptic ulcer disease.
• •5. Significant known esophageal disease, including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, diffuse esophageal spasm, and symptoms of dysmotility.
• •6. Myocardial infarction or cerebrovascular accident within past year.
• •7. Angina pectoris.
• •8. Inability to extend neck or fully open mouth.
• •9. Clinically severe cervical spinal disease, including cervical disc disease, vertebral osteophytes.
• •10. Critically loose teeth.
• •11. Temporomandibular joint syndrome (TMJ) or patients at risk for developing TMJ.
• •12. Severe coagulopathy (prothrombin time \> 3 seconds over control or platelet count \< 100,000)
• •13. Gastroparesis
• •14. Upper GI bleeding conditions such as esophageal or gastric varices, portal hypertensive gastropathy, congenital or acquired intestinal telangiectasis.
• •15. Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
• •16. Structural abnormalities of the GI tract such as diverticulum.
• •17. Lesions with increased risk of bleeding.
• •18. Hiatal hernia ≥ 2cm.
• •19. Severe cardiopulmonary disease or other serious organic disease, including HIV or cancer.
• •20. Congestive heart failure.
• •21. Uncontrolled hypertension (systolic \>150 or diastolic \> 100).
• •22. Advanced rheumatoid arthritis.
• •23. Severe or advanced liver disease (such as cirrhosis, chronic hepatitis, portal hypertension, etc.).
• •24. Chronic pancreatitis.
• •25. Any contraindication to endoscopy.
• •26. Severe reflux disease.
• •27. Currently pregnant or nursing.
• •28. Potentially childbearing (i.e. not post-menopausal or surgically sterilized) and not willing to use an effective method of contraception for the next 24 months.
• •29. Alcohol (\> 80 gm/day of ethanol) or illicit drug use within the last 3 years.
• •30. Prior gastric, esophageal, pancreatic or bariatric surgery.
• •31. Currently on prescription or over the counter diet drugs.
• •32. Chronic therapy with aspirin, NSAID or anticoagulants.
• •33. Systemic infection at the time of the procedure.
• •34. Patient with a known diagnosis or pre-existing symptoms of autoimmune connective tissue disease (i.e., systemic lupus erythematosus or scleroderma).
• •35. Thyroid disease which is not controlled with medication
• •36. Unacceptable medical risk (general health status would preclude surgery should a complication occur).
• •37. Not ambulatory.
• •38. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.