Actively Recruiting
CVS-Notifier 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
N/A
Total Duration
On this page
Sponsors
I
IHU Strasbourg
Lead Sponsor
S
Scialytics SAS
Collaborating Sponsor
AI-Summary
What this Trial Is About
Laparoscopic cholecystectomy is the preferred surgical method for gallbladder removal but carries a risk of bile duct injury, which can increase mortality and healthcare costs. The Critical View of Safety (CVS) technique helps prevent these injuries but is underused in practice. This study evaluates the CVS-Notifier Software as a Medical Device (SaMD), designed to remind surgeons to verify CVS during surgery, aiming to improve safety without disrupting surgical workflow. The CVS-Notifier SaMD will be connected to the laparoscopic video system and display a visual reminder on an auxiliary operating room screen when surgeons begin dissecting the hepatocystic triangle. This reminder prompts a time-out to confirm CVS achievement before dividing the cystic duct, as recommended by guidelines. This single-center, exploratory study will enroll patients undergoing elective laparoscopic cholecystectomy to assess the safety, usability, and impact of this device. Participants will undergo standard surgical procedures with the CVS-Notifier active. After surgery, both surgeons and patients will complete surveys about their experience. Researchers will collect clinical, surgical, and device-related data, focusing on complications related to the CVS-Notifier within 30 days after surgery. Additional measures include rates of intraoperative time-outs, CVS implementation, and acceptance by surgeons and patients. The study aims to improve surgical safety during gallbladder removal.
CONDITIONS
Brief 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 with benign gallbladder disease requiring elective laparoscopic cholecystectomy
- No contraindications to anesthesia or laparoscopic cholecystectomy surgery
- Able to understand and provide written consent
- Affiliated with the French social security system
You will not qualify if you...
- Malignant gallbladder disease requiring laparoscopic cholecystectomy
- Pregnant or lactating patient
- Currently or previously participating in another study exclusion period
- Under guardianship, trusteeship, protection of justice, or deprived of liberty
- Emergency surgery situation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the procedure
Participants undergo elective laparoscopic cholecystectomy with the CVS-Notifier device installed to remind surgeons to verify the Critical View of Safety during surgery.
1 surgical procedure visit (in-person)
Duration - Up to 30 days after surgery
Participants are monitored for device-related complications and complete surveys about their experience before discharge and up to 30 days after surgery.
Approximately 1 follow-up visit before discharge and 1 follow-up visit up to 30 days after surgery
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
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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