Hot AXIOS System Japan Post Market Survey
- Conditions
- Pancreatic Pseudocyst InfectionPancreatic PseudocystWalled Off NecrosisWalled Off Necrosis Infection
- Interventions
- Device: EUS-guided fistulization AXIOS
- Registration Number
- NCT03797209
- Lead Sponsor
- Boston Scientific Japan K.K.
- Brief Summary
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Patient who received implant procedure using study device at Japanese site.
- NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AXIOS Patient EUS-guided fistulization AXIOS -
- Primary Outcome Measures
Name Time Method 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.
Safety (Adverse Events and Device Malfunction) From implant procedure to 7 days after removal 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Aichi Medical University Hospital
🇯🇵Nagakute-Shi, Aichi, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya-Shi, Aichi, Japan
Chiba University Hospital
🇯🇵Chiba-Shi, Chiba, Japan
Nagoya University Hospital
🇯🇵Nagoya-Shi, Aichi, Japan
Kameda Medical Center
🇯🇵Kamogawa-Shi, Chiba, Japan
Tokyo Women's Medical University Yachiyo Medical Center
🇯🇵Yachiyo-Shi, Chiba, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka-Shi, Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka-Shi, Fukuoka, Japan
Kobe University Hospital
🇯🇵Kobe-Shi, Hyogo, Japan
Hyogo College of Medicine Hospital
🇯🇵Nishinomiya-Shi, Hyogo, Japan
Kagoshima University Hospital
🇯🇵Kagoshima-Shi, Kagoshima, Japan
Shonan Kamakura General Hospital
🇯🇵Kamakura-Shi, Kanagawa, Japan
Kitasato University Hospital
🇯🇵Sagamihara-Shi, Kanagawa, Japan
Yokohama Rosai Hospital
🇯🇵Yokohama-Shi, Kanagawa, Japan
Mie University Hospital
🇯🇵Tsu-Shi, Mie, Japan
Tohoku University Hospital
🇯🇵Sendai-Shi, Miyagi, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata-Shi, Niigata, Japan
Kawasaki Medical School General Medical Center
🇯🇵Okayama-Shi, Okayama, Japan
Okayama University Hospital
🇯🇵Okayama-Shi, Okayama, Japan
Kindai University Hospital
🇯🇵Osakasayama-Shi, Osaka, Japan
Saitama Medical Universtity International Medical Center
🇯🇵Hidaka-Shi, Saitama, Japan
Osaka Medical College Hospital
🇯🇵Takatsuki-Shi, Osaka, Japan
Saitama Medical Center
🇯🇵Kawagoe-Shi, Saitama, Japan
Kitasato University Medical Center
🇯🇵Kitamoto-Shi, Saitama, Japan
Tokyo Medical University Hospital
🇯🇵Tokyo, Shinjuku-Ku, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke-Shi, Tochigi, Japan
Saiseikai Utsunomiya Hospital
🇯🇵Utsunomiya-Shi, Tochigi, Japan
Juntendo University Hospital
🇯🇵Bunkyo-Ku, Tokyo, Japan
Toho University Ohashi Medical Center
🇯🇵Meguro-Ku, Tokyo, Japan
The Jikei University Hospital
🇯🇵Minato-Ku, Tokyo, Japan
Kyorin University Hospital
🇯🇵Mitaka-Shi, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama-Shi, Wakayama, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-Shi, Chiba, Japan
Teine Keijinkai Hospital
🇯🇵Sapporo-Shi, Hokkaido, Japan
Yokohama City University Medical Center
🇯🇵Yokohama-Shi, Kanagawa, Japan
Sendai Open Hospital
🇯🇵Sendai-Shi, Miyagi, Japan
University of Miyazaki Hospital
🇯🇵Miyazaki-Shi, Miyazaki, Japan
Osaka City University Hospital
🇯🇵Osaka-Shi, Osaka, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan