Surgical VR developer Augmedics said last week it began the first-in-human clinical trial of its Xvision-spine augmented reality surgical navigation center.
The trial was launched at at Israel’s Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, led by co-principal investigators Dr. Ran Harel and Dr. Yigal Mirovsky.
The Xvision-spine system is an AR surgical navigation system intended to allow surgeons to see internal anatomy during surgery with intentions to make surgeries safer and faster. The system includes a transparent near-eye display headset, with navigation data projected onto the surgeon’s retina using the headset. Traditional navigation data is projected, as well as the position of surgical tools in real-time and super-imposed patient CT data.
The open label, prospective, single arm, multi-center study aims to enroll between 8 and 22 subjects, depending on the number of screws placed in each subject, aiming for a minimum of 85 total screws placed throughout the entire study.
The first case in the trial was completed on August 5, the company said, with cases slated to continue for approximately three months. Screw placement will be assessed by two independent radiologists using the Gertzbein score, and usability will be evaluated by a user experience questionnaire.
“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,” CEO Nissan Elimelech said in a press release.
Last September, Augmedics said that it raised $8.3 million in a Series A funding round to support its ViZOR system.
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