For Healthcare Professionals

Clinical Trial of EPASS With Hot AXIOS System


About the study

A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Unresectable malignant duodenal obstruction confirmed by biopsy
  2. Eligible for endoscopic intervention
  3. GOOSS score of 0 or 1
  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


Exclusion Criteria:

  1. GOO symptoms are not expected to improve after the index procedure
  2. Life expectancy is about 3 months or less, which is not assumed applicable for surgical GJ
  3. Prior metallic stent placement for GOO
  4. Contraindicated to surgery and general anesthesia
  5. Neoplasm invading the target site of puncture in gastric and/or jejunum
  6. Abnormal coagulation INR > 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation
  7. Bleeding diathesis
  8. Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage
  9. Presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure
  10. Intervening gastric varices or vessels at the target site of stent insertion
  11. Ascites that may interfere the safety of the index procedure
  12. Biliary tract obstruction requiring treatment at the same day of the index procedure
  13. Allergic to any of the device materials
  14. Contraindications to use of electrosurgical devices
  15. Pregnancy, breastfeeding or intending to become pregnant during the study period
  16. Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the study sponsor)
  17. Vulnerable subject
  18. Subject has other reason not to be eligible for this study per investigators' discretion
  19. Guidewire doesn't cross the area of GOO
  20. EP-DB doesn't advance to the target site in jejunum
  21. The distance between the gastric wall and jejunal wall when visualized on ultrasound after saline is introduced into the space between the two inflated balloons of EP-DB is deemed about 2 cm or more
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Gastric Outlet Obstruction

Age (in years)



Not Applicable

Participants needed


Est. Completion Date

Oct 31, 2024

Treatment type



Boston Scientific Corporation identifier


Study number


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