AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

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Conditions studied: Gastric Outlet Obstruction

In brief

To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.

Key facts

Study ID

NCT06174805

Run by

Boston Scientific Corporation

People needed

67

Starts

2025-02-11

Expected to finish

2027-04-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gastric outlet obstruction from unresectable malignant neoplasm
• Eligible for endoscopic intervention
• GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
• 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
• The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm

You may not qualify if…

• Patients with baseline ECOG > 2 and/or Karnofsky Performance score < 30
• Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
• 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
• Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
• 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
• Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1.0 cm at the proposed site of AXIOSTM stent insertion
• Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
• Ascites Grade ≥ 2 confirmed by cross-sectional imaging
• Vessels located within a two-centimeter radius of the device insertion location
• History of multiple abdominal surgeries and/or evidence of small bowel adhesions
• Allergic to any of the device materials
• Contraindications to use of electrical devices
• Pregnancy
• Prisoners and other vulnerable populations

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• New York Presbyterian/ Weill Cornell Medical Center — New York, New York, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• UZ Leuven — Leuven, Belgium
• Instituto do Cancer do Estado de Sao Paulo — São Paulo, Brazil
• McGill University Health Care — Montreal, Canada
• Shanghai Changhai Hospital — Shanghai, Shanghai Municipality, China
• Asian Institute of Gastroenterology — Hyderabad, India

Full record on ClinicalTrials.gov

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