Trials / Completed
CompletedNCT05644951
Clinical Trial of EPASS With Hot AXIOS System
A Prospective, Multi-center, Single-arm Study for Unresectable Malignant Gastric Outlet Obstruction With EUS-guided Double-balloon-occluded Gastrojejunostomy Bypass
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)
Detailed description
Primary objective is to investigate the safety and effectiveness of the AXIOS™ lumen-apposing Metal Stent used in the EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for the management of symptoms associated with gastric outlet obstruction (GOO) secondary to malignant unresectable neoplasm. Primary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hot AXIOS system used for EPASS | EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system |
Timeline
- Start date
- 2022-12-23
- Primary completion
- 2024-12-05
- Completion
- 2025-08-29
- First posted
- 2022-12-09
- Last updated
- 2025-12-03
Locations
6 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05644951. Inclusion in this directory is not an endorsement.