Clinical Trial of EPASS With Hot AXIOS System

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

Detailed Description
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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.

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

Conditions
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Gastric Outlet Obstruction

Intervention / Treatment
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* Device: Hot AXIOS system used for EPASS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hot AXIOS system<br>Hot AXIOS system (20 mm diameter stent) | Device: Hot AXIOS system used for EPASS<br>* EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GOOSS 3 rate without MAE | GOOSS 3 rate without MAE | 30 days post index-procedure |