AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Exclusion Criteria

• •1. Patients with baseline ECOG \> 2 and/or Karnofsky Performance score \< 30
• •2. Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
• •3. Abnormal coagulation INR \> 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation, and/or any underlying condition associated with high risk of bleeding
• •4. Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
• •5. Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography
• •6. Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1.0 cm at the proposed site of AXIOSTM stent insertion
• •7. Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
• •8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging
• •9. Vessels located within a two-centimeter radius of the device insertion location
• •10. History of multiple abdominal surgeries and/or evidence of small bowel adhesions
• •11. Allergic to any of the device materials
• •12. Contraindications to use of electrical devices
• •13. Pregnancy
• •14. Prisoners and other vulnerable populations