NCT06174805

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Outlet Obstruction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-11
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2023-12-18
• Last updated: 2026-03-17

Locations

10 sites across 6 countries: United States, Belgium, Brazil, Canada, China, India

Regulatory

• FDA-regulated device study