Robotic bronchoscope system shows high diagnostic yield

Key takeaways:

• A robotic electromagnetic navigation bronchoscopy system had high diagnostic yield, accuracy, sensitivity and specificity.
• Adverse events reported after bronchoscopy were unrelated to the system.

Among patients with moderate-risk peripheral lung nodules, a robotic bronchoscopy system had high diagnostic yield, according to results published in Respirology.

Noah Medical’s Galaxy System is a “robotic electromagnetic navigation bronchoscopy system with integrated digital tomosynthesis technology,” according to researchers.

Song Liu

“This was the first-in-human trial of the Galaxy system,” Song Liu, MD, PhD, director of clinical affairs at Noah Medical, told Healio.

Liu, who was not one of the study authors, said it was important to note that it was conducted in Australia, where the health care system’s economics limit physicians’ ability to use robots in clinical settings.

“The trial results are significant because they indicate that even in areas where physicians have a limited amount of prior robotic experience, the Galaxy System can be used successfully with our recommended training,” Liu continued.

“This has the potential to enable many more clinicians in many more regions worldwide to perform robotic bronchoscopy procedures and improve lung cancer detection rates,” she said.

In the single-arm, single-center, prospective FRONTIER study, Tajalli Saghaie, MD, respiratory and sleep physician at Macquarie University and co-principal investigator of the study, and colleagues assessed 18 patients (mean age, 64.7 years; 52.6% women) with a moderate-risk peripheral lung nodule (n = 19; one patient with two nodules) to evaluate the safety and diagnostic yield of the Galaxy System.

As Healio previously reported, the FDA granted 510(k) clearance to the Galaxy System in March 2023.

When analyzing the 19 nodules in this population, researchers observed an average lesion size of 20 mm. Additionally, from the pleura, the nodule was 11.6 mm away on average.

A pre-specified biopsy location was set for each nodule and was reached in each. Researchers also saw the tool inside every lesion via tool-in-lesion tomosynthesis technology.

Seventeen out of 19 nodules had a confirmed specific diagnosis, and malignant diagnoses were more common than benign diagnoses (13 vs. 4).

Based on the above findings, the diagnostic yield of the Galaxy System was high falling between 89.5% and 94.7%. The higher yield value was found after researchers added follow-up data for one nonspecific benign case.

Similar to diagnostic yield, the robotic navigated bronchoscopy system had high diagnostic accuracy (94.7%), sensitivity (94.4%) and specificity (100%).

“These findings were consistent with our expectations and other results,” Liu said. “Our original trial in animals, which was published in the Journal of Bronchoscopy & Interventional Pulmonology, demonstrated similar outcomes, so the study endpoints from this completed trial were anticipated. Further, the real-world outcomes demonstrated by hospitals using the Galaxy System since this study have reinforced both study findings and even improved upon them.”

In terms of safety, three patients experienced an adverse event after bronchoscopy. Two had pneumothorax and one had severe pneumonia. Only observation was needed in one of the pneumothorax cases, whereas an overnight chest drain was needed in the other case.

Rather than being related to the device itself, researchers said the adverse events were “related to the procedure.”

“It’s essential to understand that the ability to use robots to improve lung cancer detection rates is often out of reach for many countries and hospitals because of cost, expertise required and functionality,” Liu told Healio.

For example, Liu explained, the economics of Australia’s health system means doctors searching for cancer in the lungs often have to rely on hand-drawn diagrams based on CT scans, which is a challenge that many countries in Europe, South America and the broader Asia-Pacific region share.

“In the future, we will continue to conduct clinical research to study [the device’s] clinical outcomes, operational efficiency and economic impact,” Liu said.

Reference:

• Journal of Respirology published clinical trial data demonstrating the benefits of Noah Medical’s Galaxy System. https://www.noahmed.com/press-releases/journal-of-respirology-publishes-clinical-trial-data-demonstrating-the-benefits-of-noah-medicals-galaxy-system. Published June 27, 2024. Accessed June 27, 2024.