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AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE | Clinical Trials | Clareo Health

SUSPENDEDNA

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

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

NCT06174805•Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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

Montreal, Canada

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Asian Institute of Gastroenterology

Hyderabad, India

Key Dates

Start Date

February 11, 2025

Primary Completion Date

March 1, 2027

Completion Date

April 1, 2027

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

Gastric Outlet Obstruction

Interventions

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

DEVICE

Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

NCT05986890

Malignant Gastric Outlet Obstruction

View study

RECRUITINGNA

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

NCT06128018

Malignant Gastric Outlet Obstruction

View study

ENROLLING_BY_INVITATIONNA

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

NCT06567691

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Inclusion Criteria

Exclusion Criteria

Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.

ComVi and D-type Stent in Malignant GOO