Clinical trial NCT06174805: AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE
Official title: A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy With Lumen-Apposing Metal Stent for Gastric Outlet Obstruction From Malignant Unresectable Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Outlet Obstruction
Keywords: GOO
Gastric Outlet Obstruction
AXIOS
Gastroenterostomy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: Through study completion, an average of 1 year
measure: Primary Technical Success Endpoint
timeFrame: During the procedure
measure: Primary Effectiveness Endpoint
timeFrame: through 14 days after procedure
Secondary outcomes:
Other outcomes:
measure: Clinical success over time defined as improvement of GOOS by 1 point from baseline at any time during 14 days after AXIOS stent placement and GOOS remaining at 1 or more. This endpoint will be evaluated at 3 months, 6 months, and 12 months
timeFrame: Through study completion, an average of 1 year
measure: Time to resumption of oral intake after stent placement.
timeFrame: Immediately after the procedure
measure: Time to start or resume chemotherapy after AXIOSTM stent placement (where applicable)
timeFrame: Immediately after the procedure
measure: Change in Quality-of-Life score (SF-12 questionnaire) from baseline to 30 days, 3 months, 6 months, and 12 months
timeFrame: Through study completion, an average of 1 year
measure: Incidence of Device Deficiencies
timeFrame: Immediately after the procedure
measure: Incidence of Reintervention for GOO
timeFrame: Immediately after the procedure
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York Presbyterian/ Weill Cornell Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Leuven
country: Belgium
facility: UZ Leuven
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
city: Montréal
country: Canada
facility: McGill University Health Care
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
Study officials:
affiliation: Virginia Mason Medical Center
name: Shayan Irani, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: