Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT06174805
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06174805
Study Brief:
Protocol Section:
NCT06174805