AXIOS™ Stent for Gastric Outlet Obstruction
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the AXIOS™ Stent for treating gastric outlet obstruction?
Is the AXIOS Stent safe for use in humans?
How is the AXIOS™ Stent treatment different from other treatments for gastric outlet obstruction?
The AXIOS™ Stent with electrocautery-enhanced delivery is unique because it allows for a minimally invasive procedure using endoscopic ultrasound to create a bypass for obstructions, which can be particularly beneficial for patients who are not suitable for surgery. This approach contrasts with traditional surgical methods and other stent placements that may not use electrocautery or endoscopic ultrasound guidance.145910
What is the purpose of this trial?
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.
Research Team
Shayan Irani, MBBS, MD
Principal Investigator
Virginia Mason Medical Center
Eligibility Criteria
This trial is for individuals with gastric outlet obstruction or pyloric stenosis, which are conditions that block food from leaving the stomach. Participants must have symptoms due to a malignant tumor that cannot be removed by surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EUS-guided gastroenterostomy using the AXIOS lumen-apposing Metal Stent
Initial Follow-up
Participants are monitored for safety and technical success, including serious adverse events and stent patency
Extended Follow-up
Participants are monitored for clinical success and device deficiencies over time
Treatment Details
Interventions
- AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology