AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE
Purpose
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.
Condition
- Gastric Outlet Obstruction
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AXIOS(TM) Stent and Electrocautery Enhanced Delivery System |
Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm |
|
Recruiting Locations
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Virginia Mason Medical Center
Seattle, Washington 98101
Seattle, Washington 98101
More Details
- NCT ID
- NCT06174805
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
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.