To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
Study Type
OBSERVATIONAL
Enrollment
120
By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.
Safety (Adverse Events and Device Malfunction)
Time frame: From implant procedure to 7 days after removal
Placement success
AXIOS stent is placed in an appropriate position using the delivery system.
Time frame: During implant procedure
Stent retention
AXIOS stent stays at the position where it was implanted during the implant procedure.
Time frame: 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.
Time frame: From implant procedure to removal (a maximum of 60 days)
Decreased cyst size
Time frame: From implant procedure to final observation (a maximum of 60 days)
Removal success
AXIOS stent can be removed using standard endoscopic snares or forceps.
Time frame: Removal procedure (a maximum of 60 days after implant procedure)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aichi Medical University Hospital
Nagakute-Shi, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Chiba, Chiba, Japan
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National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Teine Keijinkai Hospital
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...and 30 more locations