Hot AXIOS System Japan Post Market Survey

Completed

• Conditions: Pancreatic Pseudocyst Infection; Pancreatic Pseudocyst; Walled Off Necrosis; Walled Off Necrosis Infection

• Registration Number: NCT03797209
• Lead Sponsor: Boston Scientific Japan K.K.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-09
• Study Start: 2019-01-15
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Placement success	During implant procedure	AXIOS stent is placed in an appropriate position using the delivery system.
Safety (Adverse Events and Device Malfunction)	From implant procedure to 7 days after removal
Stent lumen patency	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	From implant procedure to final observation (a maximum of 60 days)
Removal success	Removal procedure (a maximum of 60 days after implant procedure)	AXIOS stent can be removed using standard endoscopic snares or forceps.
Stent retention	From implant procedure to removal (a maximum of 60 days)	AXIOS stent stays at the position where it was implanted during the implant procedure.

Trial Locations

Locations (40)

Aichi Medical University Hospital; 🇯🇵 Nagakute-Shi, Aichi, Japan

Aichi Cancer Center Hospital; 🇯🇵 Nagoya-Shi, Aichi, Japan

Nagoya University Hospital; 🇯🇵 Nagoya-Shi, Aichi, Japan

Chiba University Hospital; 🇯🇵 Chiba-Shi, Chiba, Japan

Kameda Medical Center; 🇯🇵 Kamogawa-Shi, Chiba, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa-Shi, Chiba, Japan

Tokyo Women's Medical University Yachiyo Medical Center; 🇯🇵 Yachiyo-Shi, Chiba, Japan

National Hospital Organization Kyushu Medical Center; 🇯🇵 Fukuoka-Shi, Fukuoka, Japan

Kyushu University Hospital; 🇯🇵 Fukuoka-Shi, Fukuoka, Japan

Teine Keijinkai Hospital; 🇯🇵 Sapporo-Shi, Hokkaido, Japan

Scroll for more (30 remaining)