NCT07186803 AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
| NCT ID | NCT07186803 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Health Network, Toronto |
| Condition | Laparoscopic Cholecystectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 70 participants in total. It began in 2025-09-17 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07186803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Laparoscopic Cholecystectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07186803 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 70 participants.
Is NCT07186803 currently recruiting?
Yes, NCT07186803 is actively recruiting participants. Contact the research team at ariana.walji@uhn.ca for enrollment information.
Where is the NCT07186803 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT07186803 clinical trial?
NCT07186803 is sponsored by University Health Network, Toronto. The trial plans to enroll 70 participants.