Clinical Trial of EPASS With Hot AXIOS System

A Prospective, Multi-center, Single-arm Study for Unresectable Malignant Gastric Outlet Obstruction With EUS-guided Double-balloon-occluded Gastrojejunostomy Bypass

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

Primary objective is to investigate the safety and effectiveness of the AXIOS™ lumen-apposing Metal Stent used in the EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for the management of symptoms associated with gastric outlet obstruction (GOO) secondary to malignant unresectable neoplasm.

Primary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.

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 authorized representative (LAR) must provide written informed consent form (ICF) to participate in 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 for surgical 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 the physician) 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, another investigational trial that may confound the results of this trial (unless written approval 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 ultrasound after saline is introduced into the space between the two inflated balloons of EP-DB is deemed about 2 cm or more