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AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

NCT06174805 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Gastric Outlet Obstruction

Interventions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Shayan Irani, MBBS, MD · Virginia Mason Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2027-03-31
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • China
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174805 on ClinicalTrials.gov