Clinical Trial

Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

Study acronym: CVS-Notifier
Recruiting
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Record status
This record was last updated April 30, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
The Critical View of Safety (CVS) is universally recommended to prevent bile duct injuries in laparoscopic cholecystectomy. However, CVS is underutilized and bile duct injuries are not decreasing. The CVS-Notifier SaMD (Software as a Medical Device) reminds surgeons to verify the CVS before dividing the cystic duct, as recommended by guidelines. It is hypothesized that this systematic and timely reminder could improve the implementation of CVS without disturbing surgical workflows.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-24; most recent amendment 2025-04-29.
Status change: Not Yet Recruiting → Recruiting 2025-04-29
Trial Details
NCT Number NCT06895200
Lead Sponsor IHU Strasbourg
Collaborators: Scialytics SAS
Conditions Cholecystectomy, Laparoscopic
Enrollment 40 participants
Start Date 2025-04-03
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-04-30