Hot AXIOS System Japan Post Market Survey | NCT03797209 | Trialant

Hot AXIOS System Japan Post Market Survey | NCT03797209 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUS-guided fistulization AXIOS	Device	By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.	AXIOS Patient

Outcomes Module

Primary Outcomes

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

Contacts/Locations Module