The trial will evaluate the system’s safety and potential to measure surgical margins in real-time
Navigation Sciences has enrolled the first patient in the first-in-human clinical feasibility study of its NaviSci system for tissue-conserving removal of early-stage lung tumours.
The intelligent surgery system incorporates augmented reality and advanced software with surgical instruments to offer real-time measurement of surgical margins, thereby helping to reduce the risk of cancer recurrence and safeguard lung function.
The trial, dubbed Navigated Resection of Lung Nodules, will evaluate the system’s safety and potential to measure surgical margins in real-time in 25 patients undergoing lung surgery.
It will also assess NaviSci’s ability to incorporate and enhance the surgical workflow. Navigation Sciences is conducting the trial at Brigham and Women’s Hospital in Boston.
The system allows the physician in real-time to know accurately where the target potential tumour nodule and surrounding tissue are in contact with the surgical instrumentation and guide the surgeon on margin distance for excising the nodule.
NaviSci system consists of various components such as active and fiducial marker with an electromagnetic sensor, which will be placed next to the tumour to localise and track its position.
It also includes a surgical cutting instrument with a second electromagnetic position sensor and advanced software, which associated the sensors on the tumour with the cutting instruments and offers visual and quantitative information to measure tumour margins in real-time.
Navigation Sciences co-founder and CEO Alan Lucas said: “The NaviSci System and Intelligent Surgical approaches have great potential to dramatically increase the precision of lung and other complex cancer surgeries, improving patient outcomes and providing benefits to clinicians and providers. Successful completion of the trial will support an application to the FDA for U.S. marketing clearance.”