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Hot AXIOS System Japan Post Market Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03797209
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Japan K.K.

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

Condition or disease Intervention/treatment Phase
Pancreatic Pseudocyst Infection Pancreatic Pseudocyst Walled Off Necrosis Infection Walled Off Necrosis Device: EUS-guided fistulization AXIOS Not Applicable

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Study Type : Interventional
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Arm Intervention/treatment
Experimental: 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.




Primary Outcome Measures :
  1. Safety (Adverse Events and Device Malfunction) [ Time Frame: From implant procedure to 7 days after removal ]
  2. Placement success [ Time Frame: During implant procedure ]
    AXIOS stent is placed in an appropriate position using the delivery system.

  3. 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.

  4. 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.

  5. Decreased cyst size [ Time Frame: From implant procedure to final observation (a maximum of 60 days) ]
  6. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • NA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797209


Contacts
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Contact: Kiyoshi Ono +81.3.6853.7500 Kiyoshi.Ono@bsci.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
Boston Scientific Japan K.K.

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Responsible Party: Boston Scientific Japan K.K.
ClinicalTrials.gov Identifier: NCT03797209    
Other Study ID Numbers: E7121
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Boston Scientific Japan K.K.:
PPC
WON
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Pancreatic Pseudocyst
Necrosis
Pathologic Processes
Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases