Hot AXIOS System Japan Post Market Survey
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
1 other identifier
observational
120
1 country
40
Brief Summary
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
January 9, 2019
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedMarch 18, 2022
March 1, 2022
1.8 years
September 25, 2018
March 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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)
Study Arms (1)
AXIOS Patient
Interventions
By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.
Eligibility Criteria
Patient who received implant procedure using study device at Japanese site.
You may qualify if:
- Patient who received implant procedure using study device at Japanese site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Aichi Medical University Hospital
Nagakute-Shi, Aichi-ken, 480-1195, Japan
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
Kameda Medical Center
Kamogawa-Shi, Chiba, 296-8602, Japan
National Cancer Center Hospital East
Kashiwa-Shi, Chiba, 277-8577, Japan
Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo-Shi, Chiba, 276-8524, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido, 006-8555, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Hyogo College of Medicine Hospital
Nishinomiya-Shi, Hyōgo, 663-8501, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520, Japan
Shonan Kamakura General Hospital
Kamakura-Shi, Kanagawa, 247-8533, Japan
Kitasato University Hospital
Sagamihara-Shi, Kanagawa, 252-0375, Japan
Yokohama Rosai Hospital
Yokohama, Kanagawa, 222-0036, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Sendai Open Hospital
Sendai, Miyagi, 983-0824, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
Kawasaki Medical School General Medical Center
Okayama, Okayama-ken, 700-8505, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
Kindai University Hospital
Osakasayama-Shi, Osaka, 589-8511, Japan
Osaka Medical College Hospital
Takatsuki-Shi, Osaka, 569-8686, Japan
Saitama Medical Universtity International Medical Center
Hidaka-Shi, Saitama, 350-1298, Japan
Saitama Medical Center
Kawagoe-Shi, Saitama, 350-8550, Japan
Kitasato University Medical Center
Kitamoto-Shi, Saitama, 364-8501, Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-Ku, 160-0023, Japan
Jichi Medical University Hospital
Shimotsuke-Shi, Tochigi, 329-0498, Japan
Saiseikai Utsunomiya Hospital
Utsunomiya, Tochigi, 321-0974, Japan
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431, Japan
Toho University Ohashi Medical Center
Meguro-Ku, Tokyo, 153-8515, Japan
The Jikei University Hospital
Minato-Ku, Tokyo, 105-8471, Japan
Kyorin University Hospital
Mitaka-Shi, Tokyo, 181-8611, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2018
First Posted
January 9, 2019
Study Start
January 15, 2019
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
March 18, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share