Clinical Trial Protocol of Primary Study on Efficacy and Safety of Telesurgery for Patients With Tumors of the Urinary System Using Chinese Independently Developed "MicroHand" Surgical Robot System

Detailed Summary

One-arm clinical trial was adopted in this study. The surgeons performed remote urological surgery for patients through domestically produced "MicroHand" surgical robot system (Shandong Weigao Co., Ltd). The "MicroHand" surgical robot system consists of two physically separated subsystems named the "surgeon console" and "patient side cart". The surgeon console includes a stereo image viewer, two master manipulators, a control panel and several foot pedals. The patient side cart includes a passive arm that can slide in the up-down direction and be adjusted forward and backward, a swivel head that can rotate around the vertical axis, and three slave arms (one for the endoscopic camera and the other two for surgical instruments). The surgeon console (based in Qingdao) takes the surgeon's input and translates it into a control signal. After network transmission, the patient side cart (based in Anshun) translates the control signal into actual instrument manipulation. The 3D images captured by the endoscopic camera were simultaneously sent back to the screen of the surgeon console as visual feedback. Data between the surgeon console and the patient side cart were transmitted through a 5G network. The safety and effectiveness of the robotic system in remote clinical diagnosis and treatment were verified by the main judgment criterion and secondary judgment criterion. Six patients are planned to enroll in the clinical trial. Main judgment criterion: The robot-assisted telesurgery did not transfer to other types of surgery, such as open surgery or normal robot-assisted surgery. Secondary judgment criterion: operative time, blood loss, postoperative pain, preoperative adjusting time and hospitalization time. Patient enrollment: This trial aims to explore the safety and effectiveness of the domestically produced robotic system in remote clinical diagnosis and treatment through 5G network. Six patients are planned to enroll in the clinical trial, including 2 patients with adrenal tumor, 2 patients with bladder cancer and 2 patients with renal cell carcinoma.

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