Trials / Completed
CompletedNCT03525808
AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component \>30%.
Detailed description
This study is a prospective, single arm, multi-center trial. Treatment of up to 40 patients will take place at up to 6 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days stent indwell and 6 months follow-up after stent removal.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AXIOS | Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall. |
Timeline
- Start date
- 2018-09-05
- Primary completion
- 2020-03-31
- Completion
- 2020-10-02
- First posted
- 2018-05-16
- Last updated
- 2021-12-20
- Results posted
- 2021-12-20
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03525808. Inclusion in this directory is not an endorsement.