AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE (NCT06174805) | Clinical Trial Compass
SuspendedNot Applicable
AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE
Stopped: Sponsor Decision
United States, Belgium, Brazil67 participantsStarted 2025-02-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Safety Endpoint
Timeframe: Through study completion, an average of 1 year
. 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 gastroenterostomy
. 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 1.0 cm at the proposed site of AXIOSTM stent insertion
. Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
. Ascites Grade ≥ 2 confirmed by cross-sectional imaging