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
|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|
|Study Type :||Interventional|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- Safety (Adverse Events and Device Malfunction) [ Time Frame: 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.
- 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.
- 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.
- Decreased cyst size [ Time Frame: 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.
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
|Contact: Kiyoshi Ono||+81.3.6853.7500||Kiyoshi.Ono@bsci.com|