Trials / Completed
CompletedNCT03797209
Hot AXIOS System Japan Post Market Survey
A Post Market Survey to Detect Information of Adverse Events and Device Malfunctions of AXIOS Stent and Electrocautery Enhanced Delivery System Under Real World Medical Condition in Japan
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (actual)
- Sponsor
- Boston Scientific Japan K.K. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
Conditions
- Pancreatic Pseudocyst Infection
- Pancreatic Pseudocyst
- Walled Off Necrosis Infection
- Walled Off Necrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EUS-guided fistulization AXIOS | By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage. |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2020-10-30
- Completion
- 2020-10-30
- First posted
- 2019-01-09
- Last updated
- 2022-03-18
Locations
40 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03797209. Inclusion in this directory is not an endorsement.