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. Led by Co-Principal Investigators Dr. Ran Harel and Prof. Yigal Mirovsky, the open label, prospective, single arm, multi-center study will evaluate the safety, performance, accuracy and usability of XVS during spine fusion procedures involving pedicle screw placement. The number of subjects will range from eight to 22, depending on the number of screws placed in each subject, with a minimum of 85 total screws placed in the study.
Augmedics reported the first human case was completed August 5, with cases expected to continue for approximately three months. Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists using the Gertzbein score (GS). Usability will be evaluated using a User Experience Questionnaire (UEQ), which wil be completed by the surgeons at the end of each procedure.
Augmedics’ xvision-spine system (XVS) is an augmented-reality surgical navigation system designed to give surgeons “X-ray vision” during complex procedures. With XVS, surgeons can see and navigate inside a patient’s body through skin and tissue, which may lead to easier, faster and safer surgeries. The XVS system comprises a transparent near-eye-display headset and has all elements of traditional navigation systems. It accurately determines the position of surgical tools, in real-time, and superimposes them on patient’s CT data. The navigation data is then projected onto the surgeon’s retina using the transparent near-eye-display headset, allowing surgeons to simultaneously look at their patient and see the navigation data without averting their eyes to a remote screen.
XVS has the potential for use in many procedures, with its first intended use in minimally invasive or open spine surgeries. XVS uses patented see-through optics to project a 3D image of a patient’s spine, as well as axial and sagittal planes, onto a surgeon’s retina, in real-time, with surgical precision and outstanding depth perception.
“This first-in-human study is a critical step towards providing surgeons a more intuitive way to navigate in surgery that allows them to always keep their eyes on the patient,” said Nissan Elimelech, CEO of Augmedics. “We believe that XVS has the potential to deliver precise results and easier, faster and safer surgeries.”
The first-in-human clinical trial follows Augmedics’ successful second cadaver study, which was completed in November 2017 by four surgeons in Baltimore, Maryland.