Under way, not recruiting
Efficacy and Safety of a Novel ERCP Robot in the Treatment of Common Bile Duct Stone
NCT07368335 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated 26 Jan 2026
- What is being tested
- Robotic-assisted ERCP; Conventional ERCP
- For
- ERCP; Robot Surgery; Common Bile Duct Stone
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 80 years. About 200 people. The full rules are on the registry page.
- Where
- China
- When
- Starts or started 24 Dec 2025, ends 30 Dec 2026. Registered 26 Jan 2026.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical SchoolNanjing, Jiangsu, China
