MedTrace Logo

Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

NCT06895200 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-30

No results posted yet for this study

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.

Conditions

  • Cholecystectomy, Laparoscopic

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.

Sponsors & Collaborators

  • Scialytics SAS

    collaborator UNKNOWN

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Silvana PERRETTA, MD, PhD · Hopitaux Universitaires de Strasbourg

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • France

Study Locations

More Related Trials

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 NCT06895200 on ClinicalTrials.gov