An interventional study of CVS-Notifier SaMD in Cholecystectomy, Laparoscopic, sponsored by IHU Strasbourg. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by IHU Strasbourg · Not applicable, Interventional, and Device feasibility
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.
Laparoscopic cholecystectomy is the gold standard approach for the surgical removal of the gallbladder. However, between 0.3 and 1.5% of patients undergoing laparoscopic cholecystectomy experience a bile duct injury (BDI). This major complication translates into a threefold increase in mortality at 1 year, frequent medico-legal litigations, and an annual cost of about 1 billion dollars in the USA alone.
The visual perceptual illusion causing major BDIs can be prevented by implementing the Critical View of Safety (CVS). CVS consists of the clearance of the hepatocystic triangle from fat and connective tissue, the division of the lower part of the gallbladder from its liver bed, and ensuring that only two tubular structures-the cystic duct and the cystic artery-connected to the gallbladder are visible. Unfortunately, CVS implementation in surgical practices is as low as 9% and, in turn, BDIs do not decrease.
To improve the implementation of the CVS, multi-society consensus guidelines recommend to time-out to confirm CVS achievement before dividing cystic structures. A large quality improvement study demonstrated that a short time-out to recall CVS principles significantly increases CVS implementation rates. However, the implementation of the time-out and CVS decreases over time.
The CVS-Notifier SaMD reminds surgeons to time-out to verify the CVS before the division of the cystic duct. Such a systematic intraoperative reminder to implement best practices could help consistently perform safe laparoscopic cholecystectomies.
This first-in-human, exploratory study aims at evaluating the safety, usability, and potential impact of the CVS-Notifier SaMD in laparoscopic cholecystectomy.
The study is a single center, non-comparative, case series. Patients undergoing elective laparoscopic cholecystectomy who meet the eligibility criteria and express their consent to participate in the study will be enrolled. The CVS-Notifier SaMD will be installed on a medical grade computer connected to a secondary output of the laparoscopic video system (input) and to an auxiliary screen in the operating room (OR) (output). Surgeons will start the procedure as usual while the CVS-Notifier SaMD unobtrusively analyses the surgical video. When the beginning of the hepatocystic triangle dissection is detected, a visual reminder to verify CVS in an intraoperative time-out notification will appear on the auxiliary OR screen.
Surgeons and patients will be asked to fill in a survey to report their experience, after the procedure and before discharge, respectively.
Clinical, surgical, and device-related data will be collected and analyzed.
IHU Strasbourg is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: CVS-Notifier SaMD
The CVS-Notifier SaMD reminds surgeons to time-out to check the CVS before the division of the cystic duct.
Rate of CVS-Notifier SaMD related complications
The rate of CVS-Notifier SaMD related complications defined as any complications caused directly or indirectly by the device. Postoperative complication will be classified according to the Clavien-Dindo classification (Grade 1 to Grade 5).
Time frame: From the day of the procedure up to 30 days after surgery
Rate of intraoperative time-out
The rate of intraoperative time-out is defined as a pause in surgical activities lasting at least 2 seconds before clipping and cutting the cystic duct or the cystic artery.
Time frame: The day of the procedure
Rate of CVS implementation
The rate of implementation of the CVS will be assessed postoperatively on surgical videos
Time frame: The day of the procedure
Surgeons' acceptance
Surgeons' use and acceptance of the technology will be assessed with a specifically designed survey
Time frame: The day of the procedure
Patients' acceptance
Patients' acceptability and expectations on the device will be assessed with a specifically designed survey
Time frame: The day of the procedure
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for May 2026, 13 months after the start.
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