AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

July 30, 2026

Conditions
Laparoscopic Cholecystectomy
Interventions
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.

Trial Locations (2)

M5G 2C4

RECRUITING

Toronto General Hospital, Toronto

M5T 2S8

RECRUITING

Toronto Western Hospital, Toronto

All Listed Sponsors
lead

University Health Network, Toronto

OTHER

NCT07186803 - AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial | Biotech Hunter | Biotech Hunter