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2019-01-15
2020-10-30
2020-10-30
120
NCT03797209
Boston Scientific Japan K.K.
Boston Scientific Japan K.K.
OBSERVATIONAL
Hot AXIOS System Japan Post Market Survey
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-09-25 | N/A | 2022-03-17 |
2019-01-08 | N/A | 2022-03-18 |
2019-01-09 | N/A | 2022-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : AXIOS Patient | DEVICE: EUS-guided fistulization AXIOS
|
| Primary Outcome Measures | 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) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
