Clinical Trials

Inclusion Criteria:

1. Gastric outlet obstruction from unresectable malignant neoplasm

2. Eligible for endoscopic intervention

3. GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 -
low-residue or full diet

4. 18 years of age or older

5. Willing and able to comply with the study procedures or legally authorized
representative (LAR) must provide written informed consent form (ICF) to participate
in the study

6. The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm

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 drainage

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 than 1.0 at the proposed site of AXIOSTM stent insertion

7. Gastric varices located within a 3.5-4 cm of the device insertion location on the
gastric wall

8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging

9. Vessels located within 3.5-4 cm of the pathway from the device insertion location on
the gastric wall to the device insertion location of the small bowel wall

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/21/23. Questions regarding updates should be directed to the study team contact.