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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ stent placement through stent removal, approximately 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stent placement through stent removal, approximately 60 days
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 moreTrial 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
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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
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