The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

Exclusion Criteria

• •1. Receiving insulin therapy
• •2. Taking GLP-1, Amylin treatment (Byetta, Symlin)
• •3. Blood pressure levels of \>180/100
• •4. Patients with an EF less than 35% (obtained within last 6 months) or indicated for an ICD; if echocardiogram outdated or unavailable, procedure to be done
• •5. Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
• •6. Use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment
• •7. Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
• •8. Prior wound healing problems due to Staphylococcus and Candida
• •9. Prior bariatric surgery
• •10. History of pancreatitis
• •11. History of peptic ulcer disease within 5 years of enrollment
• •12. Diagnosed with gastroparesis
• •13. Use of active medical devices (either implantable or external) such as ICD, pacemaker, neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
• •14. Cardiac history that physician feels should exclude the patient
• •15. Use of another investigational device or agent in the 30 days prior to enrollment
• •16. A history of life-threatening disease within 5 years of enrollment
• •17. Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study