Recruiting

Artificial Intelligence Guidance in Laparoscopic Cholecystectomy Safety

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What is being tested

Artificial Intelligence Guidance Models

Device
Who is being recruted

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorUniversity Health Network, Toronto
Study ContactAriana Walji, BSc, MSc Candidate
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 17, 2025

Actual date on which the first participant was enrolled.

This study focuses on using artificial intelligence (AI) to potentially make laparoscopic gallbladder surgeries safer. Laparoscopic cholecystectomy is a minimally invasive surgery to remove the gallbladder, and achieving the Critical View of Safety is crucial to avoid complications. This research is conducted at two hospitals in Toronto, Canada, and involves surgeons and fellows performing surgeries. The study compares procedures done with AI guidance to standard procedures. AI models provide real-time feedback to help surgeons during the operation, and the study aims to see if this guidance improves the safety of the surgery. During the trial, 10 surgeons or fellows will perform 5 surgeries each, with some using AI assistance and others following standard methods. The AI group uses tools that help ensure safe dissection and proper visibility of critical structures. Outcomes are measured by reviewing internal video recordings of the surgeries to see if the AI contributes to safer procedures. Other aspects being evaluated include how often dissections occur safely, feedback from the surgeons about the AI, and observations made by the research team. Researchers will also check patient health records 30 days after surgery to assess any differences in recovery or complications between the two groups.

Official TitleEvaluating the Clinical Impact of Artificial Intelligence on Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Principal SponsorUniversity Health Network, Toronto
Study ContactAriana Walji, BSc, MSc Candidate
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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.

2 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Surgeons or fellows in the intervention group will have access to two AI models during their procedure. A research coordinator will operate and monitor the AI models, which are displayed on a single monitor in the operating room. Participants may request to toggle between models or turn them off at any point during the procedure, as per their needs.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Toronto General Hospital

Toronto, CanadaOpen Toronto General Hospital in Google Maps
Recruiting

Toronto Western Hospital

Toronto, Canada
Recruiting
2 Study Centers