AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Gastric Outlet Obstruction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174805
• Other study ID #: E7152
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Boston Scientific Corporation
• Contact: Evelyne Ho, MPH, MBA
• Phone: (978) 483-8856
• Email: Evelyne.Ho[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study is a prospective multi-center, single -arm study with treatment of up to 59 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 59
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 drainage

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 than 1.0 at the proposed site of AXIOSTM stent insertion

7. Gastric varices located within a 3.5-4 cm of the device insertion location on the gastric wall

8. Ascites Grade = 2 confirmed by cross-sectional imaging

9. Vessels located within 3.5-4 cm of the pathway from the device insertion location on the gastric wall to the device insertion location of the small bowel wall

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

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Device:
• 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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	UZ Leuven	Leuven
Brazil	University of Sao Paulo, Instituto do Cancer do Estado de Sao Paulo	São Paulo
Canada	McGill University Health Care	Montréal
India	Asian Institute of Gastroenterology	Hyderabad
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	New York Presbyterian/ Weill Cornell Medical Center	New York	New York
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical success defined as improvement of Gastric Outlet Obstruction Score (GOOS) by 1 point from baseline at any time during 14 days after AXIOS stent placement and GOOS remaining at 1 or more.	A patient undergoing reintervention for GOO is considered a failure of clinical success	During 14 days after procedure
Other	Time to resumption of oral intake after stent placement.		Immediately after the procedure
Other	Time to start or resume chemotherapy after AXIOSTM stent placement (where applicable)		Immediately after the procedure
Other	Change in Quality-of-Life score (SF-12 questionnaire) from baseline to 30 days, 3 months, 6 months, and 12 months		Through study completion, an average of 1 year
Other	Incidence of device deficiencies including but not limited to stent migration, stent occlusion, leakage at site of stent placement.		Immediately after the procedure
Other	Incidence of Reintervention for GOO, defined as need for repeat treatment for persistent or recurrent GOO symptoms		Immediately after the procedure
Primary	AXIOSTM stent related or AXIOSTM stent placement procedure related serious adverse events through 30 days post stent placement.		Through study completion, an average of 1 year
Primary	Technical Success: Successful stent placement, defined as transmural placement of the AXIOSTM stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOSTM stent lumen.	Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement.	During the procedure