Clinical Trial of EPASS with Hot AXIOS System

Inclusion Criteria:

• Unresectable malignant duodenal obstruction confirmed by biopsy

• Eligible for endoscopic intervention

• GOOSS score of 0 or 1

• 18 years of age or older

• Willing and able to comply with the study procedures or legally authorizedrepresentative (LAR) must provide written informed consent form (ICF) to participatein the study

Exclusion Criteria:

• GOO symptoms are not expected to improve after the index procedure

• Life expectancy is about 3 months or less, which is not assumed applicable forsurgical GJ

• Prior metallic stent placement for GOO

• Contraindicated to surgery and general anesthesia

• Neoplasm invading the target site of puncture in gastric and/or jejunum

• Abnormal coagulation INR > 1.5 and not correctable (per the discretion of thephysician) or who require continuous complete anticoagulation

• Bleeding diathesis

• Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus,stomach and duodenum that might preclude endoscopic drainage

• Presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure

• Intervening gastric varices or vessels at the target site of stent insertion

• Ascites that may interfere the safety of the index procedure

• Biliary tract obstruction requiring treatment at the same day of the index procedure

• Allergic to any of the device materials

• Contraindications to use of electrosurgical devices

• Pregnancy, breastfeeding or intending to become pregnant during the study period

• Subject is currently participating, or plans to participate in, anotherinvestigational trial that may confound the results of this trial (unless writtenapproval is received from the study sponsor)

• Vulnerable subject

• Subject has other reason not to be eligible for this study per investigators'discretion

• Guidewire doesn't cross the area of GOO

• EP-DB doesn't advance to the target site in jejunum

• The distance between the gastric wall and jejunal wall when visualized on ultrasoundafter saline is introduced into the space between the two inflated balloons of EP-DBis deemed about 2 cm or more