Two hospitals in Israel, Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, have begun first-in-human clinical trial of Augmedics’ xvision-spine (XVS) augmented-reality surgical navigation system.
This trial is led by co-principal investigators Dr. Ran Harel and Prof. Yigal Mirovsky. It is an open label, prospective, single arm, multi-centre trial to analyse the safety, performance, precision and usability of XVS during spine fusion procedures that involve placement of pedicle screw.
The number of patients for this trial will range from eight to 22, based on the number of screws placed in each patient, with a minimum of 85 total screws placed in the study.
The company completed the first human case on 5 August, with cases expected to continue for around three months.
The accuracy of placement of pedicle screw will be reviewed by two independent radiologists using the Gertzbein score (GS).
For usability criteria, a User Experience Questionnaire (UEQ) will be used. This will be completed by the surgeons at the end of every surgical procedure.
The xvision-spine system (XVS) is an augmented-reality surgical navigation system intended to provide “X-ray vision” during complex procedures to surgeons.
With the help of XVS, surgeons will be able to see and navigate inside a patient’s body through skin and tissue, resulting in easier, faster and safer surgeries.
This system consists of a transparent near-eye-display headset and has all elements of traditional navigation systems.
It precisely determines the position of surgical tools, in real-time, and then superimposes them on patient’s CT data. Following this, the navigation data is projected onto the surgeon’s retina making use of the transparent near-eye-display headset, thereby enabling surgeons to simultaneously look at their patient and see the navigation data without shifting their eyes to a remote screen.
XVS makes use of patented see-through optics to project a 3D image of a patient’s spine, as well as axial and sagittal planes in real time onto a surgeon’s retina.