NCT03808272

AXIOS CHINA (E7148)

A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of AXIOS Stent and Electrocautery-enhanced Delivery System in Chinese Patients With Pancreatic Pseudocyst and Walled-off Necrosis(WON)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese population, to support the regulatory approval by CFDA

Conditions

• Pancreatic Pseudocyst and Walled-off Necrosis

Interventions

Type	Name	Description
DEVICE	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System	The HOT AXIOS Stent and Electrocautery- Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content.

Timeline

• Start date: 2019-04-17
• Primary completion: 2020-12-24
• Completion: 2021-10-30
• First posted: 2019-01-17
• Last updated: 2023-11-15

Locations

1 site across 1 country: China