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Device

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System for Acute Cholecystitis

N/A
Waitlist Available
Led By Shayan Irani, MBBS, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative (stent removal)
Awards & highlights

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.

Eligible Conditions
  • Acute Cholecystitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stent placement through stent removal, approximately 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and stent placement through stent removal, approximately 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Days to Resolution of Acute Cholecystitis
Secondary outcome measures
Rate of Re-interventions
Other outcome measures
Acute Cholecystitis Recurrence
Number of Cumulative Hospital and ICU Days
Number of Participants With Successful Technical Stent Placement.
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AXIOS(TM) Stent and Electrocautery Enhanced Delivery SystemExperimental Treatment1 Intervention
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
2019
N/A
~30

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
737 Previous Clinical Trials
854,206 Total Patients Enrolled
Shayan Irani, MBBS, MDPrincipal InvestigatorVirginia Mason Medical Center
1 Previous Clinical Trials
67 Total Patients Enrolled
~5 spots leftby Sep 2025
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