Clinical trial · Observational
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
NCT03797209CI-TRIAL-00057212completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Pseudocyst | — | UNRESOLVED | — |
| Pancreatic Pseudocyst Infection | — | UNRESOLVED | — |
| Walled Off Necrosis | — | UNRESOLVED | — |
| Walled Off Necrosis Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided fistulization AXIOS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- AXIOS Patient
- interventionNames
- Device: EUS-guided fistulization AXIOS
Primary outcomes (6)
- measure
- Safety (Adverse Events and Device Malfunction)
- timeFrame
- From implant procedure to 7 days after removal
- measure
- Placement success
- timeFrame
- During implant procedure
- description
- AXIOS stent is placed in an appropriate position using the delivery system.
- measure
- Stent retention
- timeFrame
- From implant procedure to removal (a maximum of 60 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patient who received implant procedure using study device at Japanese site. Exclusion Criteria: * NA
References
Publications (0)
Data not yet available
No reference posted for this study.