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RECRUITING
NCT06895200
NA

Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

Sponsor: IHU Strasbourg

View on ClinicalTrials.gov

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.

Official title: CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-04-03

Completion Date

2026-05

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

DEVICE

CVS-Notifier SaMD

The CVS-Notifier SaMD reminds surgeons to time-out to check the CVS before the division of the cystic duct.

Locations (1)

Visceral and Digestive Surgery, Nouvel Hôpital Civil

Strasbourg, France