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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03797209

Enrollment

120

Registered

2019-01-09

Start date

2019-01-15

Completion date

2020-10-30

Last updated

2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Pseudocyst, Pancreatic Pseudocyst Infection, Walled Off Necrosis, Walled Off Necrosis Infection

Keywords

PPC, WON

Brief summary

To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.

Interventions

DEVICEEUS-guided fistulization AXIOS

By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patient who received implant procedure using study device at Japanese site.

Exclusion criteria

* NA

Design outcomes

Primary

Measure	Time frame	Description
Safety (Adverse Events and Device Malfunction)	From implant procedure to 7 days after removal	—
Placement success	During implant procedure	AXIOS stent is placed in an appropriate position using the delivery system.
Stent retention	From implant procedure to removal (a maximum of 60 days)	AXIOS stent stays at the position where it was implanted during the implant procedure.
Stent lumen patency	From implant procedure to removal (a maximum of 60 days)	The lumen of AXIOS stent is patent, and it can be used for drainage etc.
Decreased cyst size	From implant procedure to final observation (a maximum of 60 days)	—
Removal success	Removal procedure (a maximum of 60 days after implant procedure)	AXIOS stent can be removed using standard endoscopic snares or forceps.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026