Actively Recruiting
Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
Led by IHU Strasbourg · Updated on 2025-04-30
40
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
I
IHU Strasbourg
Lead Sponsor
S
Scialytics SAS
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Visceral and Digestive Surgery, Nouvel Hôpital Civil
Strasbourg, France, 67000
Actively Recruiting
Research Team
A
Armelle TAKEDA, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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