Testing Artificial Intelligence Guidance Models for laparoscopic cholecystectomy
Official title: AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Evaluating the Clinical Impact of Artificial Intelligence on Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- Phase 3
- 2 groups
- 2 sites in Toronto
- Recruiting
Interventions
- Medical device
Artificial Intelligence Guidance Models
The intervention will involve the use of two artificial intelligence (AI) models to provide surgical guidance during laparoscopic cholecystectomy procedures. The AI models will provide real-time feedback based on the live surgical feed (internal patient anatomy captured by laparoscopic camera) displayed on an operating room monitor. The GoNoGoNet model identifies safe and unsafe zones of dissection. This is done by showcasing a green overlay over safe zones of dissection, and a red overlay over unsafe zones of dissection. The DeepCVS model provides text-based feedback based on its assessment of the following three criteria defining the Critical View of Safety: 1) complete clearance of the hepatocystic triangle from fat and fibrous tissue, 2) only two structures visible entering the gallbladder (cystic artery and duct) and 3) the lower third of the gallbladder must be dissected off the liver bed, exposing the cystic plate.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario
- Recruiting
Toronto Western Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for4 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Surgeon participants: Attending surgeons or fellows that perform laparoscopic cholecystectomy at University Health Network.
- +Patients participants: Adults 18 years of age and over, scheduled for laparoscopic cholecystectomy surgery.
Exclusion
- −Surgeon participants: Anyone who is not a surgeon or fellow at University Health Network or that does not perform laparoscopic cholecystectomies.
- −Patient participants: Any patient who is not having a laparoscopic cholecystectomy surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives no study treatment and is followed for comparison.
Registry label: A: Standard Surgical Procedure
Group B receives Artificial Intelligence Guidance Models.
Registry label: B: Artificial Intelligence Feedback
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 70 people.
The study is currently expected to finish around July 2026.
The main measurement is taken over: Post-procedure through study completion (up to 1 year).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Critical View of Safety Achievement Rate — measured over Post-procedure through study completion (up to 1 year).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07186803 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Artificial Intelligence Guidance ModelsDevice
The intervention will involve the use of two artificial intelligence (AI) models to provide surgical guidance during laparoscopic cholecystectomy procedures. The AI models will provide real-time feedback based on the live surgical feed (internal patient anatomy captured by laparoscopic camera) displayed on an operating room monitor. The GoNoGoNet model identifies safe and unsafe zones of dissection. This is done by showcasing a green overlay over safe zones of dissection, and a red overlay over unsafe zones of dissection. The DeepCVS model provides text-based feedback based on its assessment of the following three criteria defining the Critical View of Safety: 1) complete clearance of the hepatocystic triangle from fat and fibrous tissue, 2) only two structures visible entering the gallbladder (cystic artery and duct) and 3) the lower third of the gallbladder must be dissected off the liver bed, exposing the cystic plate.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Post-procedure through study completion (up to 1 year).
The study as a whole is currently expected to finish around 2026-07-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 70 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Today, the majority of gallbladder removals surgeries are done using minimally invasive techniques through small cuts to help patients recover faster. However, these procedures are technically more challenging because surgeons have a restricted view of the patient's anatomy, which can increase the risk of serious complications. Artificial intelligence (AI) tools have been developed to guide surgeons during surgery and help them make safer decisions that reduce the risk of injury to the patient. This study will use a randomized controlled trial to compare outcomes between surgeries with AI assistance and standard procedures without AI. Primary Objective: To determine whether the AI improves surgeons' ability to achieve the Critical View of Safety, a key step for safe gallbladder removal, compared to standard procedures. Secondary Objectives: * Determine whether the AI helps the surgeon perform more safe dissections compared to the standard procedures. * Collect surgeon feedback on the use of AI during the procedure
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.