Hot AXIOS System Japan Post Market Survey

Pancreatic Pseudocyst Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797209
• Other study ID #: E7121
• Status: Completed
• Start date: January 15, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: March 2022
• Source: Boston Scientific Japan K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Necrosis
• Pancreatic Pseudocyst
• Pancreatic Pseudocyst Infection
• Walled Off Necrosis
• Walled Off Necrosis Infection

Intervention

Device:
• EUS-guided fistulization AXIOS
By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.

Locations

Country	Name	City	State
Japan	Juntendo University Hospital	Bunkyo-Ku	Tokyo
Japan	Chiba University Hospital	Chiba-Shi	Chiba
Japan	Kyushu University Hospital	Fukuoka-Shi	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka-Shi	Fukuoka
Japan	Saitama Medical Universtity International Medical Center	Hidaka-Shi	Saitama
Japan	Kagoshima University Hospital	Kagoshima-Shi	Kagoshima
Japan	Shonan Kamakura General Hospital	Kamakura-Shi	Kanagawa
Japan	Kameda Medical Center	Kamogawa-Shi	Chiba
Japan	National Cancer Center Hospital East	Kashiwa-Shi	Chiba
Japan	Saitama Medical Center	Kawagoe-Shi	Saitama
Japan	Kitasato University Medical Center	Kitamoto-Shi	Saitama
Japan	Kobe University Hospital	Kobe-Shi	Hyogo
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	University of Miyazaki Hospital	Miyazaki-Shi	Miyazaki
Japan	Aichi Medical University Hospital	Nagakute-Shi	Aichi
Japan	Aichi Cancer Center Hospital	Nagoya-Shi	Aichi
Japan	Nagoya University Hospital	Nagoya-Shi	Aichi
Japan	Niigata University Medical and Dental Hospital	Niigata-Shi	Niigata
Japan	Hyogo College of Medicine Hospital	Nishinomiya-Shi	Hyogo
Japan	Kawasaki Medical School General Medical Center	Okayama-Shi	Okayama
Japan	Okayama University Hospital	Okayama-Shi	Okayama
Japan	Osaka City University Hospital	Osaka-Shi	Osaka
Japan	Kindai University Hospital	Osakasayama-Shi	Osaka
Japan	Kitasato University Hospital	Sagamihara-Shi	Kanagawa
Japan	Teine Keijinkai Hospital	Sapporo-Shi	Hokkaido
Japan	Sendai Open Hospital	Sendai-Shi	Miyagi
Japan	Tohoku University Hospital	Sendai-Shi	Miyagi
Japan	Jichi Medical University Hospital	Shimotsuke-Shi	Tochigi
Japan	Keio University Hospital	Shinjuku-Ku	Tokyo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-Ku	Tokyo
Japan	Osaka Medical College Hospital	Takatsuki-Shi	Osaka
Japan	Tokyo Medical University Hospital	Tokyo	Shinjuku-Ku
Japan	Mie University Hospital	Tsu-Shi	Mie
Japan	Saiseikai Utsunomiya Hospital	Utsunomiya-Shi	Tochigi
Japan	Wakayama Medical University Hospital	Wakayama-Shi	Wakayama
Japan	Tokyo Women's Medical University Yachiyo Medical Center	Yachiyo-Shi	Chiba
Japan	Yokohama City University Medical Center	Yokohama-Shi	Kanagawa
Japan	Yokohama Rosai Hospital	Yokohama-Shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Adverse Events and Device Malfunction)		From implant procedure to 7 days after removal
Primary	Placement success	AXIOS stent is placed in an appropriate position using the delivery system.	During implant procedure
Primary	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)
Primary	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)
Primary	Decreased cyst size		From implant procedure to final observation (a maximum of 60 days)
Primary	Removal success	AXIOS stent can be removed using standard endoscopic snares or forceps.	Removal procedure (a maximum of 60 days after implant procedure)