AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Not Applicable

Recruiting

• Conditions: Gastric Outlet Obstruction
• Interventions: Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

• Registration Number: NCT06174805
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

The study is a prospective multi-center, single -arm study with treatment of up to 67 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.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-18
• Study Start: 2025-02-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2027-02
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. Gastric outlet obstruction from unresectable malignant neoplasm
2. Eligible for endoscopic intervention
3. GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
4. 18 years of age or older
5. 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
6. The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm

Exclusion Criteria

1. Patients with baseline ECOG > 2 and/or Karnofsky Performance score < 30
2. Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
3. 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
4. Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
5. 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
6. 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
7. Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging
9. Vessels located within a two-centimeter radius of the device insertion location
10. History of multiple abdominal surgeries and/or evidence of small bowel adhesions
11. Allergic to any of the device materials
12. Contraindications to use of electrical devices
13. Pregnancy
14. Prisoners and other vulnerable populations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System	AXIOS(TM) Stent and Electrocautery Enhanced Delivery System	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

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	through 14 days after procedure	Clinical Success defined as improvement of Gastric Outlet Obstruction Score (GOOS)by 1 point from baseline to any point during 14 days after AXIOS stent placement and GOOS remaining at 1 or more without the need for reintervention due to loss of stent function at 30 days post-index procedure or death, whichever comes first.
Primary Safety Endpoint	Through study completion, an average of 1 year	AXIOS stent related or AXIOS endoscopic and/or study procedure related serious adverse events through 30 days post stent placement.
Primary Technical Success Endpoint	During the procedure	Successful stent placement, defined as transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS 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. Note: 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.

Trial Locations

Locations (10)

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; 🇨🇦 Montréal, Canada

Shanghai Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, India