At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
AXIOS(TM) Stent and Electrocautery Enhanced Delivery Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
In Brief
A clinical study evaluating AXIOS(TM) Stent and Electrocautery Enhanced Delivery System for Cholecystitis, Acute. Completed, enrolled 30 participants across 7 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholecystitis, Acute
CountriesBelgium, United States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartSep 2019
Primary CompletionDec 2021
TodayJul 2026
First PostedDec 7, 2018
Enrollment StartSep 10, 2019
Primary CompletionDec 2, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.6 years ago
Interventions
AXIOS(TM) Stent and Electrocautery Enhanced Delivery Systemdevice
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.