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AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE

Cholecystitis, Acute Clinical Trial

Official title:
A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage

Clinical Trial Summary

To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.

Clinical Trial Description

This study is a prospective, single arm, multi center trial. Treatment of up to 30 patients will take place at up to 9 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03767881
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date September 10, 2019
Completion date December 2, 2021
View Details
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