Subject demographics |
 • Age |
 • Sex |
 • Ethnicity |
 • Race |
Subject medical history and baseline status |
 • Prior invasive lung procedures and surgeries |
 • Lung function and diffusing capacity |
 • Antithrombotic medication current and prior status, including duration of any discontinuation |
 • Subject risk factors |
 • Pre-procedure probability of malignancy |
 • Quality of life (EQ-5D) |
Lesion characteristics |
 • Size |
 • Location |
 • Presence of bronchus sign on computerized tomography (CT) |
 • Lung zone (peripheral, middle, and proximal thirds) |
 • Visibility on fluoroscopy (if applicable) |
 • Positron emission tomography (PET)-positive (yes/no) |
 • Associated lymphadenopathy |
 • Distance to closest fissure |
 • Distance from lesion to pleura |
 • Preprocedure probability of malignancy (investigator assessment) |
Procedural assessments |
 • Indication for procedure |
 • Anesthesia type |
 • Catheter type |
 • Procedure duration |
 • Imaging used (fluoroscopy, PET, radial endobronchial ultrasound [EBUS]) |
 • Ability to successfully navigate to lesion |
 • Use of associated tools and type (e.g., access tools, biopsy forceps, cytology brush, aspiration needle) |
 • Number of lesions biopsied |
 • Number of lymph nodes biopsied (if applicable) |
 • Placement of fiducial markers (if applicable), type used, indication, and status at follow-up imaging |
 • Surgical resection, including use of dye marker, type used, and adequacy for surgical resection |
 • Diagnosis by both cytologic rapid on-site evaluation (ROSE) and pathology |
 • Cancer type (primary or metastatic), if applicable |
 • Cancer stage, if applicable |
 • Adequacy of sample for molecular testing and mutation type (if applicable) |
 • Lymph node number, station, size, and success in obtaining sample (if applicable) |
 • Number and type of repeat electromagnetic navigational bronchoscopy (ENB) procedures or other biopsies |
 • Other health services (e.g., imaging, transfusion, surgery, emergency room admission, prescriptions) received during admission for index procedure |
 • Hospital admission duration |
 • Adverse events, action taken, relationship to device, and outcome |
Follow-up assessments |
 • Subject satisfaction (at 1-month follow-up only) |
 • Subject quality of life (EQ-5D) at all follow-up visits |
 • ENB Productivity and Activity Questionnaire (ENB-PAQ) at 1 month visit |
 • All health services (e.g., imaging, transfusion, surgery, emergency room admission, prescriptions) received since last visit |
 • All healthcare services related to lung health since index procedure (e.g., primary care and specialist visits, hospital, emergency room, oncology, radiology, pain management). |
 • All therapeutic and diagnostic procedures and diagnoses related to lung health since last visit |
 • Adverse events, action taken, relationship to device, and outcome |