Placement of the AXIOS stent to manage symptoms of Gastric Outlet Obstruction.

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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 cm

Exclusion Criteria

Patients with baseline ECOG greater than 2 and or Karnofsky Performance score less than 30

Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent

Abnormal coagulation INR greater than 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 drainage

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 cm at the proposed site of AXIOSTM stent insertion

Gastric varices located within a 3.5-4 cm of the device insertion location on the gastric wall

Ascites Grade greater than or equal to 2 confirmed by cross-sectional imaging

Vessels located within 3.5-4 cm of the pathway from the device insertion location on the gastric wall to the device insertion location of the small bowel wall

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AXIOS stent related or AXIOS endoscopic and/or study procedure related Serios Adverse Events through 30 days post stent placementTimepoint: At the time of the stent placement through study completion, an average of 1-year.

Secondary Outcome Measures