Navigation Sciences has commenced the first-in-human clinical feasibility trial of its NaviSci System, which is used for tissue-conserving removal of early-stage lung tumours.
The Intelligent Surgery System is designed to provide real-time ‘GPS’ guidance to the surgeon, providing precise knowledge of where the target tumour and surrounding tissue are in relationship to surgical instrumentation.
Accordingly, the surgeon will be guided to determine the margin distance to excise the tumour.
The system, which integrates augmented reality and advanced software with surgical instruments, is based on technology that is exclusively licensed from the Brigham and Women’s Hospital.
It is claimed to be the first system designed to measure surgical margins in real-time, which helps reduce the risk of cancer recurrence and conserve lung function.
The clinical feasibility trial, ‘Navigated Resection of Lung Nodules,’ is being conducted at Brigham and Women’s Hospital located in Boston, US.
It will evaluate the ability and safety of the NaviSci system to measure surgical margins in real-time in 25 patients undergoing lung surgery.
The trial will also evaluate the potential of integrating the system and improving the surgical workflow.
Navigation Sciences co-founder and CEO Alan Lucas said: “The clinical trial marks an important milestone for the NaviSci System’s development and the company.
“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 Food and Drug Administration (FDA) for US marketing clearance.”
According to the company, more than 225,000 new cases of lung cancer are being diagnosed in the US a year, of which more than 76,000 are early-stage tumours.