Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

Exclusion Criteria

• •Subjects will be excluded from the study for any of the following:
• •1. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
• •2. Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
• •3. Previous mal-absorptive or restrictive procedures performed for the treatment of obesity;
• •4. Scheduled concurrent surgical procedure;
• •5. Participation in any other investigational device or drug study (non survey based trial) within 12 weeks of enrollment;
• •6. Any condition which precludes compliance with the study, including:
• •1. Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;
• •2. Congenital or acquired anomalies of the GI tract, including atresias or stenosis;
• •3. Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
• •4. Uncontrolled hypertension;
• •5. Portal hypertension;
• •6. Treatment with insulin (more than 50 units a day);
• •7. Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
• •8. Cirrhosis;
• •9. Congenital or acquired intestinal telangiectasia;
• •10. Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus;
• •11. Presence of hiatal hernia;
• •12. Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
• •13. Pancreatitis;
• •14. Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
• •15. Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
• •7. History or presence of pre-existing autoimmune connective tissue disease;
• •8. Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.