Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign

Lung cancer remains a leading cause of cancer-related mortality worldwide, and delayed diagnosis is an important contributor to poor clinical outcomes. Earlier and more accurate diagnosis of small peripheral pulmonary nodules may facilitate timely clinical decision-making and treatment.

The Ion Endoluminal System is a robotic-assisted bronchoscopy platform designed to provide access to peripheral pulmonary lesions. When integrated with mobile cone-beam computed tomography (mCBCT), the system may provide additional imaging information to support localization of small pulmonary nodules during bronchoscopic biopsy. However, prospective clinical data on the diagnostic performance of this integrated approach in small, bronchus sign-negative pulmonary nodules remain limited.

ROBISN is a prospective, multicenter, observational study designed to evaluate the clinical performance of bronchoscopic biopsy using the integrated Ion Endoluminal System and mCBCT platform in patients with small peripheral pulmonary nodules that are considered challenging for conventional bronchoscopic biopsy.

The study will enroll adult patients who are already clinically planned to undergo bronchoscopic biopsy using the Ion Endoluminal System and mCBCT as part of their routine clinical care. Eligible patients will have a single target pulmonary nodule with a maximum diameter of 20 mm or less, measured on axial, sagittal, and coronal computed tomography images. The target nodule must also be bronchus sign-negative on thin-section computed tomography.

This is an observational study, and participation in the study will not determine the patient's clinical diagnostic or treatment pathway. All bronchoscopic procedures, imaging, biopsy techniques, pathology assessments, subsequent diagnostic evaluations, and treatment decisions will be performed according to the participating institution's standard clinical practice and the treating physician's judgment.

The study will prospectively collect information related to patient and target lesion characteristics, procedural details, use of adjunctive imaging and biopsy modalities, biopsy results, pathology findings, procedure-related adverse events, and subsequent clinical information used to establish the final diagnosis of the target pulmonary nodule.

Diagnostic outcomes will be assessed using information obtained from the index bronchoscopic biopsy together with subsequent pathology, imaging, clinical follow-up, or other diagnostic procedures, as applicable. Follow-up information will be collected prospectively to evaluate the diagnostic outcome of cases in which the initial biopsy result is not immediately definitive and to characterize the clinical course of the target lesion over time.

Safety outcomes will include clinically relevant procedure-related adverse events, including events such as pneumothorax and bleeding. Other procedural and clinical variables will also be collected to characterize the performance of the integrated Ion Endoluminal System and mCBCT approach in this patient population.

The results of this study are intended to provide prospective, multicenter evidence regarding the use of robotic-assisted bronchoscopy combined with mCBCT for the biopsy of small, bronchus sign-negative pulmonary nodules and to better characterize its diagnostic performance and safety in routine clinical practice.