Skip to main content
OpenTrials
Completed

NCT Number: NCT03797209

Hot AXIOS System Japan Post Market Survey

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Pseudocyst Infection Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases Pancreatic Pseudocyst Walled Off Necrosis Walled Off Necrosis Infection

Sex eligibility

All sexes

Study type

Observational

Primary location

Aichi Medical University Hospital, Nagakute-Shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • NA

Treatment and study plan

EUS-guided fistulization AXIOS

Device

By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Japan K.K.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2019
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.