Clinical trial NCT03797209: Hot AXIOS System Japan Post Market Survey
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Pseudocyst Infection
Pancreatic Pseudocyst
Walled Off Necrosis Infection
Walled Off Necrosis
Keywords: PPC
WON
Lead sponsor: Boston Scientific Japan K.K.
Sponsor class: INDUSTRY
First posted: 2019-01-09
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who received implant procedure using study device at Japanese site.

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* NA

Primary outcomes:
measure: Safety (Adverse Events and Device Malfunction)
timeFrame: From implant procedure to 7 days after removal
measure: Placement success
timeFrame: During implant procedure
measure: Stent retention
timeFrame: From implant procedure to removal (a maximum of 60 days)
measure: Stent lumen patency
timeFrame: From implant procedure to removal (a maximum of 60 days)
measure: Decreased cyst size
timeFrame: From implant procedure to final observation (a maximum of 60 days)
measure: Removal success
timeFrame: Removal procedure (a maximum of 60 days after implant procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Nagakute-Shi
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Nagoya-Shi
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya-Shi
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Chiba-Shi
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Kamogawa-Shi
country: Japan
facility: Kameda Medical Center
state: Chiba
city: Kashiwa-Shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Yachiyo-Shi
country: Japan
facility: Tokyo Women's Medical University Yachiyo Medical Center
state: Chiba
city: Fukuoka-Shi
country: Japan
facility: National Hospital Organization Kyushu Medical Center
state: Fukuoka
city: Fukuoka-Shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Sapporo-Shi
country: Japan
facility: Teine Keijinkai Hospital
state: Hokkaido
city: Kobe-Shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Nishinomiya-Shi
country: Japan
facility: Hyogo College of Medicine Hospital
state: Hyogo
city: Kagoshima-Shi
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima
city: Kamakura-Shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Sagamihara-Shi
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Yokohama Rosai Hospital
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Tsu-Shi
country: Japan
facility: Mie University Hospital
state: Mie
city: Sendai-Shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sendai-Shi
country: Japan
facility: Sendai Open Hospital
state: Miyagi
city: Miyazaki-Shi
country: Japan
facility: University of Miyazaki Hospital
state: Miyazaki
city: Niigata-Shi
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Okayama-Shi
country: Japan
facility: Kawasaki Medical School General Medical Center
state: Okayama
city: Okayama-Shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Osaka-Shi
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Osakasayama-Shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Takatsuki-Shi
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Hidaka-Shi
country: Japan
facility: Saitama Medical Universtity International Medical Center
state: Saitama
city: Kawagoe-Shi
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Kitamoto-Shi
country: Japan
facility: Kitasato University Medical Center
state: Saitama
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
state: Shinjuku-Ku
city: Shimotsuke-Shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Utsunomiya-Shi
country: Japan
facility: Saiseikai Utsunomiya Hospital
state: Tochigi
city: Bunkyo-Ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Meguro-Ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Minato-Ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Mitaka-Shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Wakayama-Shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
Study officials:
References: