Results from the first clinical study evaluating a new flexible robotics platform suggest that using the platform is a safe and feasible approach to sample lung tissue, according to results presented at Chest 2017 and reported by under development by Intuitive Surgical.
The robotic-assisted, catheter-based technology is being designed to access hard-to-reach areas of the body through natural openings, like the mouth. When applied in the lungs, its aim is to enable early lung cancer diagnoses by accessing and sampling tissue from small nodules in difficult-to-reach areas.
This single-center study at Australia’s Royal Brisbane and Women’s Hospital was led by principle investigator, David Fielding, MD, a thoracic physician and Director of Bronchology, and co-investigator Farzad Bashirzadeh, MD, a respiratory and sleep physician at the hospital. The 30-patient study evaluated both the safety and feasibility of the platform.
In the study, a majority of the target nodules were smaller than two centimeters in diameter. In 29 of 30 cases, the pre-planned target area was reached and a sample suitable for assessment was obtained. Additionally, no device-related adverse events, or instances of pneumothorax or excessive bleeding occurred, suggesting a strong safety profile.
“I was able to reach nodules in the peripheral lung that I wouldn’t have been able to reach before,” said Dr Fielding. “The robotic-assisted technology in sampling facilitates diagnosis at a stage in which most patients wouldn’t yet know that they have cancer. Early diagnosis should allow us to start care plans for patients earlier and offer curative treatments.”
The flexible robotics platform from Intuitive Surgical is still under development, not yet 510(k) cleared by the US FDA and not for sale. The safety and effectiveness of this platform have not been established. The study was funded by Intuitive Surgical.