AXIOSâ„¢ Gastroenterostomy for Gastric Outlet Obstruction IDE (NCT06174805) | Clinical Trial Compass
SuspendedNot Applicable
AXIOSâ„¢ Gastroenterostomy for Gastric Outlet Obstruction IDE
Stopped: Sponsor Decision
United States67 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 range18 Years
SexALL
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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
✕. 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
What they're measuring
1
Primary Safety Endpoint
Timeframe: Through study completion, an average of 1 year
✕. 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