18 and older, any sex, with Cholecystitis, Acute. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Days to Resolution of Acute CholecystitisPrimary· Up to 15 weeks
Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.
Group
Value
95% CI
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
5.30
± 14.90
Rate of Re-interventionsSecondary· Through study completion, Up to 15 weeks
Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.
Group
Value
95% CI
AXIOS Stent and Electrocautery Enhanced Delivery System
5
Stent PatencySecondary· Stent placement through stent removal, approximately 60 days
Stent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOSTM stent lumen
Group
Value
95% CI
AXIOS Stent and Electrocautery Enhanced Delivery System
22
Number of Participants With Successful Technical Stent Placement.Secondary· Intraoperative (stent placement)
Technical AXIOS stent placement success, defined as transmural placement of the AXIOSTM stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOSTM stent
Group
Value
95% CI
AXIOS Stent and Electrocautery Enhanced Delivery System
28
Number of Participants With Successful Technical Stent Removal.Secondary· Intraoperative (stent removal)
Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events
Group
Value
95% CI
AXIOS Stent and Electrocautery Enhanced Delivery System
19
Acute Cholecystitis RecurrenceSecondary· Through study completion, up to 15 weeks
Recurrence of acute cholecystitis and its management post AXIOS stent removal
Group
Value
95% CI
AXIOS Stent and Electrocautery Enhanced Delivery System
3
Number of Cumulative Hospital and ICU DaysSecondary· Through study completion, up to 15 weeks
Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis
Group
Value
95% CI
AXIOS Stent and Electrocautery Enhanced Delivery System
8.30
± 7.14
Adverse events — posted to ClinicalTrials.gov
Time frame: 16 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
AXIOS Stent and Electrocautery Enhanced Delivery System
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 17 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03767881.