AUGMEDICS BEGINS SPINE NAVIGATION SYSTEM HUMAN TRIAL (Orthopedic This Week)
Yokneam, Israel-based Augmedics has begun a first-in-human clinical trial of its xvision-spine (XVS) augmented-reality surgical navigation system at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, in Israel. [ Link to Sheba Medical Center ]
Co-Principal Investigators Dr. Ran Harel and Prof. Yigal Mirovsky will lead the open label, prospective, single arm, multi-center study whose goal is to evaluate the safety, performance, accuracy and usability of XVS during spine fusion procedures involving pedicle screw placement.
The study, said Augmedics, will enroll between 8 and 22 subjects—depending on the number of screws placed in each subject. The study investigators plan to place a minimum of 85 screws with xvision-spine. The first human case was completed August 5 and the company expects that the study investigators will be able reach full enrollment in approximately three months.
Investigators will assess the accuracy of xvision-spine pedicle screw placement by using two independent, experienced radiologists using the Gertzbein score (GS). They will also evaluate the system with a User Expe...
