Cholecystectomy, LaparoscopicCVS-NotifierNCT06895200
Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
A study testing CVS-Notifier SaMD in people with Cholecystectomy, Laparoscopic, run by IHU Strasbourg at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- CVS-Notifier SaMD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Visceral and Digestive Surgery, Nouvel Hôpital Civil
Strasbourg, 67000
Silvana PERRETTA, MD, PhD, +33369550531, silvana.perretta@chru-strasbourg.fr
About this study
Official title: CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
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.
Read the detailed description
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.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- CVS-Notifier SaMD
- Keywords
- Laparoscopic cholecystectomy, Gallbladder, Safety, Critical View of Safety, CVS, Bile Duct Injuries, BDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVS-Notifier SaMDDevice
The CVS-Notifier SaMD reminds surgeons to time-out to check the CVS before the division of the cystic duct.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Not described Receives: Device: CVS-Notifier SaMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the day of the procedure up to 30 days after surgery
Secondary outcomes (4)
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.
Measured: The day of the procedure
Rate of CVS implementation
The rate of implementation of the CVS will be assessed postoperatively on surgical videos
Measured: The day of the procedure
Surgeons' acceptance
Surgeons' use and acceptance of the technology will be assessed with a specifically designed survey
Measured: The day of the procedure
Patients' acceptance
Patients' acceptability and expectations on the device will be assessed with a specifically designed survey
Measured: The day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start3 Apr 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Collaborators
- Scialytics SAS
- Responsible party
- Sponsor
- Investigators
- Silvana PERRETTA, MD, PhD, Principal investigator, Hopitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895200
- Sponsor's protocol ID
- 24-001
- Acronym
- CVS-Notifier
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06895200
- Acronym / sponsor ID
- CVS-Notifier / 24-001
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- Laparoscopic cholecystectomy, Gallbladder, Safety, Critical View of Safety, CVS, Bile Duct Injuries, BDI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Collaborators
- Scialytics SAS
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Device: CVS-Notifier SaMD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVS-Notifier SaMDThe CVS-Notifier SaMD reminds surgeons to time-out to check the CVS before the division of the cystic duct. | Device | Study |
Primary outcome
Rate of CVS-Notifier SaMD related complications
Time frame: From the day of the procedure up to 30 days after surgery
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).
4 secondary outcomes
Rate of intraoperative time-out
Time frame: The day of the procedure
Rate of CVS implementation
Time frame: The day of the procedure
Surgeons' acceptance
Time frame: The day of the procedure
Patients' acceptance
Time frame: The day of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvana PERRETTA, MD, PhD principal investigator
Hopitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVS-Notifier SaMD in people with Cholecystectomy, Laparoscopic, run by IHU Strasbourg at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armelle TAKEDA, PhD (+33341903608, armelle.takeda@ihu-strasbourg.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CVS-Notifier SaMD related complications (time frame: From the day of the procedure up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.