New clinical study results in the NHS show that shape-sensing robotic-assisted bronchoscopy using Intuitive’s Ion endoluminal system (Ion) could help patients with suspected lung cancer to receive an early diagnosis, potentially accelerating clinical intervention, referral to treatment and improving patient outcomes.
The UK-first study, which is also Europe’s first multi-centre clinical study evaluating Ion, demonstrated that the technology can enable physicians to safely and effectively reach and biopsy small nodules in difficult-to-access areas of the lung, with a high rate of diagnostic accuracy provided to patients.
Ion features an ultra-thin, shape-sensing catheter designed to navigate deep into the lung. This advanced technology enables physicians to access small, complex nodules and precisely position biopsy tools to sample potentially cancerous tissue with stability not available with manual bronchoscopy techniques.
The study enrolled 200 NHS patients at Royal Brompton Hospital and St Bartholomew’s Hospital with small, suspicious nodules to undergo biopsy using Ion in combination with cone-beam CT scan.
Published in Thorax, the study reported:
- Ninety-nine percent tool in lesion rate (198/200 patients), meaning physicians precisely placed a biopsy tool within the suspicious nodule using the Ion system
- Ninety-two percent diagnostic accuracy (184/200 patients), meaning patients had an accurate diagnosis from the biopsy tissue sample taken using Ion
Lung cancer is the most common cause of cancer death in the UK. Every year, around 49,000 people in the UK are diagnosed with lung cancer, and over half of cases are diagnosed at a late stage of the disease.
Due to challenges in securing effective biopsies for small nodules, some patients with suspected lung cancer may undergo long periods of ‘watchful waiting’ where their nodule is monitored but not definitively diagnosed. This can cause related anxiety and delays in accessing earlier treatment options.
Professor Pallav Shah, Consultant Respiratory Physician at Royal Brompton Hospital, said: “Lung screening is driving up the detection of suspicious, small lung nodules at an earlier stage – but without the means to access these nodules, it can raise questions rather than answers, and most patients are left to ‘watch and wait’ without a diagnosis.
“Now, by using Ion to reach and biopsy these nodules, we’re more likely to give patients a clear diagnosis sooner, making screening more meaningful than before. Most importantly, we can increase the chance of being able to provide curative treatment.”
Mr Kelvin Lau, Clinical Director and Consultant Thoracic Surgeon at St Bartholomew’s Hospital, said: “While lung cancer screening has made a huge impact in detecting nodules, this is only half the story – we need to know which of these nodules are cancerous so we can act on them quickly and efficiently, before the disease progresses.
“The use of Ion marks a paradigm shift in our approach to lung cancer, offering a highly accurate, less invasive method to biopsy suspicious lung nodules. At St Bartholemew’s Hospital, my patients no longer need to wait months for a repeat scan. Instead, they have a biopsy, go home on the same day, and return to normal activities almost immediately, avoiding unnecessary operations and accessing the right treatment sooner.”
Oliver Wagner, Vice President and Medical Officer, Endoluminal Division at Intuitive, said: “We know that early diagnosis is critical to helping lung cancer patients achieve the best clinical outcomes, and these study results highlight the significant impact Ion could deliver for patients across the UK and Europe as access increases. Our aim is to increase equity of access to minimally invasive care and support the positive transformation of the lung cancer pathway, helping patients get answers sooner, ultimately leading to better clinical outcomes.”
