Clinical Trial

Efficacy and Safety of a Novel ERCP Robot in the Treatment of Common Bile Duct Stone

Study acronym: ERCP
Active, Not Recruiting
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Summary
Conventional endoscopic retrograde cholangiopancreatography (ERCP) is performed under fluoroscopic guidance, exposing endoscopists to ionizing radiation and posing risks of work-related musculoskeletal injury. Robotic-assisted ERCP may mitigate these occupational hazards and potentially enhance procedural precision and stability. However, robust clinical evidence regarding its performance and safety remains limited. This prospective, multicenter, randomized controlled non-inferiority trial is designed to evaluate the efficacy and safety of an ERCP robotic system (Electronic Endoscopic Surgery System) developed by Shanghai Aohua Photoelectricity Endoscope Co., Ltd. for common bile duct stone removal. A total of at least 200 subjects will be recruited and randomized 1:1 to either the experimental group or the control group. The experimental group will undergo robotic-assisted ERCP lithotomy using the aforementioned system, while the control group will receive conventional ERCP lithotomy using a standard duodenoscope.
Trial Details
NCT Number NCT07368335
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions ERCP, Robot Surgery, Common Bile Duct Stone
Enrollment 200 participants
Start Date 2025-12-24
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-26