Hot AXIOS System Japan Post Market Survey

March 17, 2022 updated by: Boston Scientific Japan K.K.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety (Adverse Events and Device Malfunction)
Time Frame: From implant procedure to 7 days after removal
From implant procedure to 7 days after removal
Placement success
Time Frame: During implant procedure
AXIOS stent is placed in an appropriate position using the delivery system.
During implant procedure
Stent retention
Time Frame: From implant procedure to removal (a maximum of 60 days)
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
Time Frame: 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.
From implant procedure to removal (a maximum of 60 days)
Decreased cyst size
Time Frame: From implant procedure to final observation (a maximum of 60 days)
From implant procedure to final observation (a maximum of 60 days)
Removal success
Time Frame: Removal procedure (a maximum of 60 days after implant procedure)
AXIOS stent can be removed using standard endoscopic snares or forceps.
Removal procedure (a maximum of 60 days after implant procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Japan K.K.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings