AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is a prospective multi-center, single -arm study with treatment of up to 59 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the AXIOS stent and up to 12 months follow-up.

Official Title
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A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy With Lumen-Apposing Metal Stent for Gastric Outlet Obstruction From Malignant Unresectable Disease

Conditions
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Gastric Outlet Obstruction

Intervention / Treatment
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* Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System


Participation Criteria
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Eligibility Criteria
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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 1.0 cm Exclusion Criteria: 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 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 than 1.0 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 ≥ 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

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System<br>Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm | Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System<br>* Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AXIOSTM stent related or AXIOSTM stent placement procedure related serious adverse events through 30 days post stent placement. |  | Through study completion, an average of 1 year | 
| Technical Success: Successful stent placement, defined as transmural placement of the AXIOSTM stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOSTM stent lumen. | Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GOO, Gastric Outlet Obstruction, AXIOS, Gastroenterostomy