Intuitive reports interim data on robotic-assisted bronchoscopy study
A multicenter study of 155 patients has found an approximate 90% diagnostic yield for peripheral pulmonary nodules using Intuitive’s Ion system integrated with mobile cone-beam CT imaging.
Intuitive, the manufacturer of the Ion endoluminal system, has released interim results from its CONFIRM study, a prospective trial evaluating the use of shape-sensing robotic-assisted bronchoscopy in conjunction with Siemens Healthineers Cios Spin mobile cone-beam CT (mCBCT). The study tracked 155 patients with peripheral pulmonary nodules of 20 mm or less across six major U.S. medical institutions from February to December 2023.
The findings, presented at the 2024 American Association for Bronchology and Interventional Pulmonology conference, reported a diagnostic yield of approximately 90%. Researchers tracked success based on tool-in-nodule confirmation, noting that the combination of robotic navigation and real-time 3D imaging resulted in a 1.3% rate of significant intraprocedural bleeding and zero instances of pneumothorax.
While the results suggest consistent performance, the study authors acknowledged limitations, noting that the data originates from high-volume academic centers where clinicians are highly experienced. These results may not be generalizable to smaller clinical settings or less experienced practitioners. The study, which was funded by Intuitive, remains ongoing with 12-month follow-up periods for non-malignant findings.