Augmedics, a developer of technologies for future surgery, has commenced a first-in-human clinical study of its xvision-spine (XVS) augmented-reality surgical navigation system.
Under the leadership of co-principal investigators Ran Harel and professor Yigal Mirovsky, the trial was started at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center in Israel, Augmedics said.
The open label, prospective, single arm and multi-center trial will assess the safety, performance, accuracy and usability of XVS during spine fusion procedures involving pedicle screw placement.
The first-in-human clinical trial is said to follow the company’s second cadaver study, which was completed in November last year.
According to the company, the number of subjects will range from eight to 22, based on the number of screws placed in each subject, with a minimum of 85 total screws placed in the study.
Two independent and experienced radiologists will evaluate the accuracy of pedicle screw placement.
The user experience questionnaire (UEQ) will be used to assess the usability of the system. It will be completed by the surgeons at the end of each procedure.
The firm’s augmented-reality surgical navigation system will provide surgeons with X-ray vision during complex procedures.
With the support of XVS, the surgeons can view and navigate inside a patient’s body through skin and tissue, enabling to conduct faster and safer surgeries.
Augmedics’ XVs system includes transparent near-eye-display headset, as well as integrates all elements of traditional navigation systems.
The system can accurately determine the position of surgical tools in real-time and superimposes them on patient’s CT data.
Later, the navigation data is projected onto the surgeon’s retina with applying transparent near-eye-display headset, helping surgeons to simultaneously monitor the patient and view the navigation data without averting their eyes to a remote screen.
XVS can be used in multiple procedures, and its first application is in minimally invasive or open spine surgeries.
Augmedics CEO Nissan Elimelech said: “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.
“We believe that XVS has the potential to deliver precise results and easier, faster and safer surgeries.”