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

NCT03767881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-17

Study results available
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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.

Conditions

  • Cholecystitis, Acute

Interventions

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Shayan Irani, MBBS, MD · Virginia Mason Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2021-12-02
Completion
2021-12-02
FDA Device
Yes

Countries

  • United States
  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767881 on ClinicalTrials.gov