RecruitingNot Applicable

Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

France40 participantsStarted 2025-04-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Man or woman over 18 years old. * Patient presenting with benign gallbladder disease requiring an elective laparoscopic cholecystectomy. * Patient without contraindications to anaesthesia or laparoscopic cholecystectomy surgery. * Patients capable of understanding and providing their written consent to the study. * Patient affiliated to the French social security system. Exclusion Criteria: * Patients presenting with malignant gallbladder disease requiring an elective laparoscopic cholecystectomy. * Pregnant or lactating patient. * Patient in exclusion period (determined by a previous or a current study). * Patient under guardianship or trusteeship. * Patient under the protection of justice or deprived of liberty. * Patient in situation of emergency.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of CVS-Notifier SaMD related complications

Timeframe: From the day of the procedure up to 30 days after surgery

Trial details

NCT IDNCT06895200

SponsorIHU Strasbourg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Armelle TAKEDA, PhD

+33341903608 armelle.takeda@ihu-strasbourg.eu

View on ClinicalTrials.gov More Cholecystectomy, Laparoscopic trials