Recently, the EndoFaster, a digestive endoscopic surgical robot with fully independent intellectual property rights, has completed all enrollment in prospective, multicenter, and parallel controlled clinical trials for registration in China.
The EndoFaster Endoscopic Surgery Robot System is one of the world's leading natural passage surgical robots and the world's first digestive endoscopic surgery auxiliary operating system to complete human registration clinical trials.
The end of this clinical trial enrollment marks an important step for ROBO Medical in obtaining the National Drug Administration (NMPA) registration certificate. Through this clinical trial, the safety and clinical effectiveness of the EndoFaster digestive endoscopic surgery robot system of ROBO Medical have been fully verified and recognized, laying a solid foundation for its further development and application.
The ROBO medical digestive endoscopic surgery auxiliary operating system adopts an innovative micro continuous flexible robotic arm design, which brings a new breakthrough for digestive endoscopic surgery. By using the motion of a robotic arm to traction and lift the diseased tissue during endoscopic submucosal dissection (ESD), the surgical operation is closer to the doctor's intuition, thereby shortening the surgical time and reducing the probability of intraoperative complications.
The flexible arm diameter of this system can be controlled around 3mm, and precise master slave control with 4 degrees of freedom is achieved in the limited space of the digestive tract. This technological innovation greatly improves the safety of ESD, reduces the difficulty of learning the surgery, and provides a solution for the popularization and promotion of the surgical robot.
The institutions participating in this clinical trial include Shandong University Qilu Hospital, Shanghai Changhai Hospital, Binzhou Medical College Affiliated Hospital, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Zhejiang Provincial People's Hospital, and Zibo Central Hospital.