NCT03767881

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cholecystitis, Acute

Interventions

Type	Name	Description
DEVICE	AXIOS(TM) Stent and Electrocautery Enhanced Delivery System	Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.

Timeline

• Start date: 2019-09-10
• Primary completion: 2021-12-02
• Completion: 2021-12-02
• First posted: 2018-12-07
• Last updated: 2023-02-17
• Results posted: 2023-02-17

Locations

7 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated device study