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AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary completion date changed from estimate of Jun 30, 2026 to May 11, 2026 · Enrollment target: estimated 70 to confirmed 64 · Study completion date changed from estimate of Jul 30, 2026 to Aug 31, 2026 · 3 more Show 6 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2026 to May 11, 2026
    • Enrollment target: estimated 70 to confirmed 64
    • Study completion date changed from estimate of Jul 30, 2026 to Aug 31, 2026
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 4 words
  2. Start date changed from estimate of Sep 2025 to Sep 17, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07186803
Lead Sponsor University Health Network, Toronto
Conditions Laparoscopic Cholecystectomy
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov