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

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Pseudocyst; Pancreatic Pseudocyst Infection; Walled Off Necrosis Infection; Walled Off Necrosis
• Intervention / Treatment: Device: EUS-guided fistulization AXIOS

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagakute-Shi, Aichi, Japan, 480-1195
      • Aichi Medical University Hospital
    • Nagoya-Shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital
    • Nagoya-Shi, Aichi, Japan, 466-8560
      • Nagoya University Hospital
  • Chiba
    • Chiba-Shi, Chiba, Japan, 260-8677
      • Chiba University Hospital
    • Kamogawa-Shi, Chiba, Japan, 296-8602
      • Kameda Medical Center
    • Kashiwa-Shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
    • Yachiyo-Shi, Chiba, Japan, 276-8524
      • Tokyo Women's Medical University Yachiyo Medical Center
  • Fukuoka
    • Fukuoka-Shi, Fukuoka, Japan, 810-8563
      • National Hospital Organization Kyushu Medical Center
    • Fukuoka-Shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital
  • Hokkaido
    • Sapporo-Shi, Hokkaido, Japan, 006-8555
      • Teine Keijinkai Hospital
  • Hyogo
    • Kobe-Shi, Hyogo, Japan, 650-0017
      • Kobe University Hospital
    • Nishinomiya-Shi, Hyogo, Japan, 663-8501
      • Hyogo College of Medicine Hospital
  • Kagoshima
    • Kagoshima-Shi, Kagoshima, Japan, 890-8520
      • Kagoshima University Hospital
  • Kanagawa
    • Kamakura-Shi, Kanagawa, Japan, 247-8533
      • Shonan Kamakura General Hospital
    • Sagamihara-Shi, Kanagawa, Japan, 252-0375
      • Kitasato University Hospital
    • Yokohama-Shi, Kanagawa, Japan, 222-0036
      • Yokohama Rosai Hospital
    • Yokohama-Shi, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
  • Mie
    • Tsu-Shi, Mie, Japan, 514-8507
      • Mie University Hospital
  • Miyagi
    • Sendai-Shi, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
    • Sendai-Shi, Miyagi, Japan, 983-0824
      • Sendai Open Hospital
  • Miyazaki
    • Miyazaki-Shi, Miyazaki, Japan, 889-1692
      • University of Miyazaki Hospital
  • Niigata
    • Niigata-Shi, Niigata, Japan, 951-8520
      • Niigata University Medical And Dental Hospital
  • Okayama
    • Okayama-Shi, Okayama, Japan, 700-8505
      • Kawasaki Medical School General Medical Center
    • Okayama-Shi, Okayama, Japan, 700-8558
      • Okayama University Hospital
  • Osaka
    • Osaka-Shi, Osaka, Japan, 545-8586
      • Osaka City University Hospital
    • Osakasayama-Shi, Osaka, Japan, 589-8511
      • Kindai University Hospital
    • Takatsuki-Shi, Osaka, Japan, 569-8686
      • Osaka Medical College Hospital
  • Saitama
    • Hidaka-Shi, Saitama, Japan, 350-1298
      • Saitama Medical Universtity International Medical Center
    • Kawagoe-Shi, Saitama, Japan, 350-8550
      • Saitama Medical Center
    • Kitamoto-Shi, Saitama, Japan, 364-8501
      • Kitasato University Medical Center
  • Shinjuku-Ku
    • Tokyo, Shinjuku-Ku, Japan, 160-0023
      • Tokyo Medical University Hospital
  • Tochigi
    • Shimotsuke-Shi, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
    • Utsunomiya-Shi, Tochigi, Japan, 321-0974
      • Saiseikai Utsunomiya Hospital
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Meguro-Ku, Tokyo, Japan, 153-8515
      • Toho University Ohashi Medical Center
    • Minato-Ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital
    • Mitaka-Shi, Tokyo, Japan, 181-8611
      • Kyorin University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital
  • Wakayama
    • Wakayama-Shi, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AXIOS Patient	Device: EUS-guided fistulization AXIOS; By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Boston Scientific Japan K.K.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: PPC; WON
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Cysts; Pancreatic Diseases; Pancreatic Cyst; Infections; Communicable Diseases; Necrosis; Pancreatic Pseudocyst
• Other Study ID Numbers: E7121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes